Jon and all..I went over every PR at the nbix site..I realize that ya'll are more expert in insomnia by this point(lunesta/estorra etc...I can't find justification for the modified release formulation based on the studies I found..one difficulty is that some of the PR's are more detailed than others..Looking at Somaxin's doxepin P3, as a clinician and daughter of a chronic insomniac, I'd choose this one over Indiplon..Please let me know what I'm missing here..
somaxon.com
Also, I tend to agree with one of Miljenko's posts here that PFE may have underestimated SEPR/Aventis progress since they signed in 2002 for I..and also gotten sick and tired of nbix behaviour throughout this nda process?..I dunno'..speaking as a consumer? more than investor?..
All will be revealed..Say hi to the girls!~
Elisabeth
2004, 20mg/30mg MR Phase 3
Neurocrine's 'SLEEP' Study Demonstrates Highly Positive Long-Term Efficacy Results With Indiplon Modified Release
Patients Gained Up to 90 Minutes of Total Sleep Time - Sustained Throughout Study
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced a second long term Phase III trial with highly positive efficacy results from its three month pivotal study, referred to as "SLEEP," the Study of Long-term Efficacy and Safety of indiplon modified release in Primary (Chronic) Insomnia patients. Preliminary results demonstrated that patients who took indiplon modified release either 20 mg or 30 mg nightly achieved rapid sleep onset, maintained high quality sleep throughout the night, and showed improvement in quality of
life endpoints. Indiplon treatment demonstrated a highly statistically significant improvement in sleep for all primary and secondary endpoints compared to placebo for both doses and all time points (p<0.0001). Patients on both doses of indiplon reported an increase of up to 75 minutes compared to placebo in Total Sleep Time (sTST), the primary endpoint for the study, and up to 90 minutes improvement over baseline. This positive effect was sustained over the three- month period. Safety results were similar to what had been observed in other indiplon modified release studies.
"We are very pleased to report these impressive results from our SLEEP study, the first long term Phase III clinical trial with indiplon modified release, demonstrating that patients were able to resolve their many symptoms of insomnia over a prolonged treatment period. The highly beneficial effects were sustained over the three-month period of the study," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. "With the long term SLEEP and RESTFUL trials, we now have in our Phase III program a database of over 5000 patients which confirms that indiplon can significantly improve sleep in patients with transient and chronic insomnia. Indiplon has consistently demonstrated it is effective in inducing and maintaining sleep with improved sleep quality."
Results on Secondary Endpoints
Secondary sleep maintenance endpoints including patient reported Total Wake Time (sTWT), Wake After Sleep Onset (sWASO), Number of Awakenings After Sleep Onset (sNAASO) also demonstrated a highly statistically significant improvement for both doses as compared to placebo over the three-month dosing period. For sleep initiation endpoints, patient reported Latency to Sleep Onset (LSO) was also highly statistically significant for both doses compared to placebo (p<0.0001) and Sleep Quality was improved in the indiplon groups compared to placebo (p<0.0001). Evaluation of treatment response was also assessed by both patients and investigators. Indiplon demonstrated a highly statistically significant improvement in Patient Reported Outcomes including measures of Quality of Life such as Vitality, and Insomnia Severity Index when compared to placebo. Investigator reported Global Rating for Severity of insomnia and Change as a result of treatment were both highly statistically significant in favor of indiplon compared to placebo.
"The results of this study demonstrated robust long term efficacy data. There was evidence of sustained effects on all the standard measures of sleep initiation and sleep maintenance. This effect was more durable and of a greater magnitude than what we have seen in the literature to date. This trial also demonstrated consistency in patients' feelings of improved sleep quality and time asleep based on daily recordings in patient's diaries and as measured at each monthly interval of continued treatment," said Dr. Marty Scharf, Director, Tri-State Sleep Disorders Center and Clinical Professor of Psychiatry at the Wright State University Department of Psychiatry.
"There is a pressing need for newer sleep medications for long-term use, and the indiplon results released today support a greater confidence in the role sleep medications can now play in treating people with chronic insomnia. Patients in this trial reported sustained and significant quality of life changes as a result of their increased sleep time, including better next day functioning and improved work productivity and benefits," said Dr. John Winkelman, Medical Director, Sleep Health Center, Brigham and Women's Hospital. "With this new positive long-term data, physicians and also patients should feel more comfortable that drugs like indiplon can be used in the long- term management of insomnia."
Study Design
The study was a randomized, double-blind, placebo-controlled, parallel- group, multi-center, out-patient Phase III clinical trial conducted over a three month dosing period to assess the efficacy and safety of nightly administration of two doses of indiplon modified release (20 mg and 30 mg) relative to placebo in 740 adult chronic patients ages 21 to 64 years with sleep maintenance difficulties. The primary and secondary endpoints for the three-month blinded study included all standard measures of sleep maintenance and sleep quality as well as sleep initiation. In addition, patients were given questionnaires to comment on their overall well being and quality of life issues. Data for the primary and secondary endpoints were collected in patient diaries on a daily basis. The study was conducted in 70 sleep centers worldwide.
About Indiplon
Neurocrine's 'RESTFUL' Study Demonstrates Highly Positive Long-Term Efficacy Results with Indiplon Immediate Release
Sustained Effects on Sleep Initiation and Sleep Quality Over Entire Treatment Period
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive results from the pivotal long term efficacy and safety Phase III "RESTFUL" trial with indiplon immediate release in patients with chronic insomnia, achieving highly statistically significant results in sleep initiation and sleep quality that were sustained over a three month period. The study involved 700 adult patients, ages 21 to 64 years, with chronic insomnia, in which patients received nightly administration of indiplon immediate release (10 mg or 20 mg) over the three-month period. Results demonstrated that with either of two dose levels of indiplon immediate release, patients achieved rapid sleep onset and slept longer with minimal sleep disturbances. Efficacy results with indiplon immediate release 10 mg and 20 mg doses demonstrated a highly statistically significant improvement in patient reported Latency to Sleep Onset (LSO) or the time it took patients to fall asleep (p<0.001 to p<0.0001) at all time points as compared to placebo, a 30% improvement over placebo and more than 27 minutes over baseline. Safety results demonstrated that the incidence of adverse events was similar to what had been observed in other long-term indiplon studies.
"We are excited to report these robust long term results from our RESTFUL study with indiplon immediate release," commented Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. "With this study, we have now completed all seven of our Phase III trials for registration with indiplon immediate release, demonstrating consistently positive results in different patient populations. Most recently, we have also completed a six-month safety extension of a separate Phase III out-patient study in elderly patients, confirming the long-term safety and lack of tolerance of indiplon."
Results on Secondary Endpoints
Secondary endpoints including patient reported Total Sleep Time (sTST), Wake After Sleep Onset (sWASO), Number of Awakenings After Sleep Onset (sNAASO), and Sleep Quality (SQ) also demonstrated a highly statistically significant improvement for both doses as compared to placebo. Evaluation of treatment response was also assessed by both patients and investigators. Indiplon demonstrated a highly statistically significant improvement in Patient Reported Outcome (PRO) as assessed by the Insomnia Severity Index. Investigator reported Global Rating for Severity of insomnia and Change as a result of treatment were both highly statistically significant over placebo and in favor of indiplon.
Study Design
The study was a randomized, double-blind, placebo-controlled, parallel- group, multi-center, out-patient Phase III clinical trial conducted over a three month period to assess the efficacy and safety of nightly administration of two doses of indiplon immediate release (10 mg and 20 mg) relative to placebo in 700 adult chronic insomnia patients. The study was conducted in 67 centers worldwide.
About Indiplon
Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Two formulations of indiplon, immediate release and modified release, are being evaluated in clinical trials to address different types of sleep problems
About Neurocrine Biosciences
Neurocrine is conducting one of the most comprehensive clinical programs in insomnia to address the multiple needs of younger and older adult patients with insomnia such as sleep initiation, sleep maintenance, and long-term administration. Neurocrine has completed all of its Phase III safety and efficacy trials for the two formulations of indiplon to support New Drug Applications (NDAs), expected in mid-2004. The Phase III program alone will have data from approximately 5,000 patients with different types of insomnia. Indiplon was licensed from DOV Pharmaceutical in 1998.
Insomnia is a prevalent condition in the United States, with 40 percent of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35 percent of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Insomnia remains a disorder with high unmet medical needs, including prolonged awakenings during the night with difficulty falling back to sleep.
Webcast Today at the Wells Fargo Securities Healthcare Conference
Neurocrine will present at the Wells Fargo Securities Healthcare Conference at the St. Regis Hotel in New York City, today Wednesday, March 24, 2004 at 12:00 PM Eastern Standard Time and 9:00 AM Pacific Standard Time. The presentation will be simultaneously webcast and can be accessed on the Company's website at neurocrine.com. The conference format will include a presentation and fireside chat. Gary Lyons, President and Chief Executive Officer of Neurocrine will respond to questions on indiplon and will highlight results from recently completed Phase III clinical trials.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, certain female and male disorders, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at neurocrine.com
In addition to historical facts, this press release may contain forward- looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with the Company's indiplon clinical development program and planned regulatory activities. Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to, risk that indiplon may not successfully proceed through Phase III clinical trials or Phase III clinical trials may fail to demonstrate that indiplon is safe and effective in treating humans; risk that the Company may not complete indiplon Phase III clinical trials on the Company's projected timelines for various reasons, including the possibility that patient recruitment may be slower than expected; risk that the clinical investigators and contract research organizations upon which the Company relies to conduct its clinical programs may not be diligent, careful or timely, and may make mistakes, in the conduct of the programs; risk relating to the Company's dependence on contract manufacturers for clinical drug supply and compliance with regulatory requirements for marketing approval; risk that the Company may not successfully co-ordinate the completion and submission of planned regulatory filings on the Company's projected timelines; risk that the Company may not receive regulatory approval for indiplon or approval may be delayed; risks associated with the Company's dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; risk that the Company will be unable to raise additional funding required to complete development of all of its product candidates; and the other risks described in the Company's Form 10-K for the year ended December 31, 2003. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
2004 IR Phase 3(long term, chronic adult)
Neurocrine's 'RESTFUL' Study Demonstrates Highly Positive Long-Term Efficacy Results with Indiplon Immediate Release
Sustained Effects on Sleep Initiation and Sleep Quality Over Entire Treatment Period
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive results from the pivotal long term efficacy and safety Phase III "RESTFUL" trial with indiplon immediate release in patients with chronic insomnia, achieving highly statistically significant results in sleep initiation and sleep quality that were sustained over a three month period. The study involved 700 adult patients, ages 21 to 64 years, with chronic insomnia, in which patients received nightly administration of indiplon immediate release (10 mg or 20 mg) over the three-month period. Results demonstrated that with either of two dose levels of indiplon immediate release, patients achieved rapid sleep onset and slept longer with minimal sleep disturbances. Efficacy results with indiplon immediate release 10 mg and 20 mg doses demonstrated a highly statistically significant improvement in patient reported Latency to Sleep Onset (LSO) or the time it took patients to fall asleep (p<0.001 to p<0.0001) at all time points as compared to placebo, a 30% improvement over placebo and more than 27 minutes over baseline. Safety results demonstrated that the incidence of adverse events was similar to what had been observed in other long-term indiplon studies.
"We are excited to report these robust long term results from our RESTFUL study with indiplon immediate release," commented Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. "With this study, we have now completed all seven of our Phase III trials for registration with indiplon immediate release, demonstrating consistently positive results in different patient populations. Most recently, we have also completed a six-month safety extension of a separate Phase III out-patient study in elderly patients, confirming the long-term safety and lack of tolerance of indiplon."
Results on Secondary Endpoints
Secondary endpoints including patient reported Total Sleep Time (sTST), Wake After Sleep Onset (sWASO), Number of Awakenings After Sleep Onset (sNAASO), and Sleep Quality (SQ) also demonstrated a highly statistically significant improvement for both doses as compared to placebo. Evaluation of treatment response was also assessed by both patients and investigators. Indiplon demonstrated a highly statistically significant improvement in Patient Reported Outcome (PRO) as assessed by the Insomnia Severity Index. Investigator reported Global Rating for Severity of insomnia and Change as a result of treatment were both highly statistically significant over placebo and in favor of indiplon.
Study Design
The study was a randomized, double-blind, placebo-controlled, parallel- group, multi-center, out-patient Phase III clinical trial conducted over a three month period to assess the efficacy and safety of nightly administration of two doses of indiplon immediate release (10 mg and 20 mg) relative to placebo in 700 adult chronic insomnia patients. The study was conducted in 67 centers worldwide.
About Indiplon
Long-Term Study Shows Indiplon Capsules Effective at Promoting Sleep Onset and Maintenance
Data Presented at APA Annual Meeting Show Benefits Sustained Over the Course of the Treatment Period
SAN DIEGO, May 25 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that data presented at the 2005 American Psychiatric Association (APA) Annual Meeting showed that nightly administration of indiplon capsules resulted in significant and sustained improvement in sleep onset and sleep maintenance in patients with chronic insomnia over the entire treatment period. Data also showed there was no evidence of tolerance over the three months or withdrawal upon discontinuation of treatment -- complications often seen with extended use of older-generation sleep medications.
"This study demonstrates the ability of indiplon to help patients not only fall asleep but maintain sleep throughout the night and shows the effectiveness of indiplon capsules in treating the varying sleep needs of patients with insomnia," said Dr. Martin Scharf of the Tri-State Sleep Disorders Center. "Importantly, this study shows that indiplon can be given over long periods of time without inducing tolerance, a key concern to physicians treating patients with chronic insomnia. Furthermore, indiplon was shown to be safe and effective without next-day residual effects for long-term treatment of chronic insomnia."
The study, which was conducted in 67 centers worldwide, was a randomized, double blind, placebo-controlled trial evaluating the safety, efficacy, and tolerability of indiplon capsules in 702 patients with moderate to severe chronic insomnia. Patients were randomized to three months of treatment with either indiplon 10 mg or 20 mg capsules, or placebo.
Patients Consistently Fell Asleep Faster With Indiplon
The primary endpoint for the clinical study was Latency to Sleep Onset (LSO) or the time it takes patients to fall asleep, as reported by patients. Data showed that indiplon capsules resulted in significant and sustained improvements in LSO (p<0.0001 to p<0.0004) and provided patients with 50% improvement in LSO from baseline. The mean improvement from baseline LSO for the indiplon treatment groups was as high as 27.2 minutes for the 10mg group and 27.6 minutes for the 20mg group compared to a maximum of 18 minutes for the placebo group over the three-month dosing period.
Patients Gained an Hour of Sleep and Slept Through the Night
The study also assessed several subjective secondary endpoints including Total Sleep Time (sTST), Wake After Sleep Onset (sWASO) and Number of Awakenings after Sleep Onset (sNAASO) which are used to assess sleep maintenance effects. Results showed that indiplon capsules resulted in significant improvements in sTST (all p<0.0001) with patients gaining approximately one hour more of sleep during the night. Mean improvement from baseline in TST for the indiplon treatment groups was as high as 48.5 minutes for the 10mg group and 70.9 minutes for the 20mg group compared to a maximum of 27 minutes for the placebo group over the three-month treatment period.
The results also showed that indiplon significantly reduced the amount of time patients spent awake in the middle of the night (sWASO) (p<0.0001 to p<0.02). Mean improvement from baseline in WASO for the indiplon treatment groups was as high as 31.3 minutes for the 10mg group and 36.1 minutes for the 20mg group compared to a maximum of 21 minutes for the placebo group.
In addition, patients reported a statistically significant improvement in overall sleep quality.
"Neurocrine is pleased to release the results of this trial as well as the additional data being presented at the APA meeting, as we believe that they truly attest to the critical role indiplon could play in the treatment of insomnia," said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences, Inc. "The data demonstrate that indiplon is safe and effective in treating a variety of insomnia symptoms over the long-term."
Indiplon Demonstrated Safety Long-Term
This study assessed the safety of indiplon over the long-term including its potential for the development of tolerance, and the safety and tolerability of nightly use. Results underscore that the improvements in sleep provided by indiplon did not diminish over time. Adverse events were similar to what has been observed in other indiplon studies and were primarily CNS in nature. Overall there was no evidence of withdrawal symptoms after abrupt discontinuation following three months of treatment with indiplon 10mg and 20mg capsules during a one-week discontinuation period, based on results from the Benzodiazepine Symptom Withdrawal Questionnaire (BSWQ).
Data from three additional studies evaluating the safety and efficacy of indiplon are also being presented at the APA annual meeting on Wednesday, May 25, 2005 at 12:00 PM EDT.
Efficacy and Tolerability of Indiplon IR (capsules) in Elderly Patient with Chronic Insomnia
Efficacy and Tolerability of Indiplon MR (tablets) in Elderly Patients with Chronic Insomnia
Efficacy and Safety of Indiplon IR (capsules) in Adults with Chronic Insomnia Characterized by Prolonged Nighttime Awakenings with Difficulty Returning to Sleep
About Indiplon....
Studies Presented at APSS Show Indiplon Helps Elderly Patients
Fall Asleep Faster and Stay Asleep Throughout the Night
- New National Survey Shows Nearly Half of Elderly Have Trouble Sleeping -
SAN DIEGO, June 22 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that data presented this week at the Associated Professional Sleep Societies' (APSS) Annual Meeting showed that indiplon safely and effectively helps elderly patients with chronic insomnia fall asleep faster and stay asleep throughout the night. These results come on the heels of a new survey(1) which reveals the prevalence and impact of insomnia in the elderly.
<redacted>
New Studies Show Indiplon Effectively Treats Insomnia in Elderly Patients
Results were presented today from two studies evaluating the safety and efficacy of indiplon in treating patients ages 65-85 years with chronic insomnia.
Data Demonstrates Indiplon Capsules Safe and Effective in Elderly with Insomnia
The first study was a randomized, double blind, placebo-controlled Phase III trial evaluating the safety and efficacy of indiplon capsules in 358 elderly patients ages 65-80 with primary insomnia. Patients were randomized to two weeks of treatment with indiplon capsules 5 mg, 10 mg, or placebo.
The primary endpoint for the clinical study was self-reported Latency to Sleep Onset (LSO) or the time it takes patients to fall asleep. Data showed that indiplon capsules resulted in significant improvements in LSO (p<0.02 to p<0.0001) as compared to placebo. When compared to baseline values, treatment with indiplon resulted in a greater than 50% reduction in LSO. The study also assessed sleep maintenance endpoints including subjective Total Sleep Time (sTST). Results showed that sTST was significantly increased for both doses of indiplon capsules at weeks one and two (p<0.007 to p<0.0001). Overall, indiplon capsules were well tolerated in the elderly and there were statistically significant improvements in patient-reported sleep parameters associated with sleep quality.
Data Demonstrates Indiplon Tablets Effective in Elderly with Sleep Maintenance Difficulties
The second study was a double blind, placebo-controlled trial evaluating the safety and efficacy of indiplon tablets 15 mg in 229 chronic insomnia patients (ages 65-85 years) with sleep maintenance difficulties.
The primary endpoint for the study was sTST, which is used to measure sleep maintenance. Results showed that treatment with indiplon tablets resulted in significant improvement in sTST at both weeks 1 and 2 (p<0.0001) as compared to placebo. Mean improvement in sTST was approximately 50 min for the 15 mg indiplon group compared with just 16 min for placebo. The study also found that indiplon tablets significantly improved LSO at both weeks 1 and 2 (p<0.0001). Indiplon also reduced wake after sleep onset (sWASO) by more than 40 minutes from baseline. Indiplon tablets were well tolerated in the elderly and there were statistically significant improvements in patient- reported measures indicating that indiplon tablets helped overall with the time it took them to fall asleep, stay sleep throughout the night, and improve sleep quality.
"Results from these two studies demonstrate the safety of indiplon in treating insomnia in the elderly, a sensitive population that is often one of the most difficult to treat and further underscores the product's established safety profile," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer of Neurocrine Biosciences, Inc. "These data, combined with previously presented data in adults, demonstrate the flexibility of indiplon in effectively treating different types of patients as well as their different insomnia symptoms."
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