Peter,
Good PTIE results?
>>SOUTH SAN FRANCISCO, Calif., Oct. 4 /PRNewswire/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - news), a drug development company, today announced positive results from preliminary analysis of a large Phase II clinical trial with PTI-555. PTI-555 is the Company's investigational painkiller aimed at the $700 million U.S. market for morphine and similar narcotic painkillers.
The Phase II double blind, placebo controlled clinical trial enrolled 210 patients with moderate to severe pain. Immediately following oral surgery, patients received a single dose of PTI-555, morphine or placebo. The primary endpoint of pain relief was achieved with a high degree of statistical significance against both morphine (p<0.01) and placebo (p<0.001).
``As a company committed to developing novel drugs to treat people with pain, we are delighted with the outcome of this clinical trial,'' said Remi Barbier, president and chief executive officer of Pain Therapeutics, Inc. ``These results increase the certainty of our morphine program and allow us to move forward into efficacy trials in patients with severe chronic pain.''
Details of the Company's preliminary analysis for this clinical trial are summarized below.
``These positive results are an important clinical milestone for our initiative to develop a drug that's better than morphine,'' said Barry Sherman, MD, executive vice president and chief medical officer of Pain Therapeutics, Inc. ``The novel pharmacological theory that low doses of opioid antagonists can improve the performance of opioid agonists, such as morphine, continues to be supported in large numbers of patients.''
Clinical Trial Details
Trial Design
This Phase II trial was a multi-center, randomized, double blind, placebo and active controlled human clinical trial comparing PTI-555 to morphine sulfate and placebo. The trial enrolled 210 patients with moderate to severe pain following major oral surgery significant enough to warrant opioid analgesia. Immediately after surgery, patients were randomly assigned to receive a single oral nominal dose of PTI-555, morphine sulfate or placebo. PTI-555 is the Company's proprietary combination of morphine sulfate and low-dose naltrexone. The primary efficacy endpoint in this trial was pain relief within eight hours of dosing.
Clinical Results
The primary efficacy endpoint was achieved with a high degree of statistical significance, even though this trial was not powered to generate statistically meaningful efficacy data. The following results were observed in this trial:
Patients given a single oral dose of PTI-555 90mg achieved significantly more total pain relief over four hours (TOTPAR4) compared to patients given a single 90mg dose of oral morphine sulfate (p<0.01), with no significant change in the incidence of side-effects.
Patients given a single oral dose of PTI-555 90mg achieved significantly more total pain relief over four hours (TOTPAR4) compared to patients given placebo (p<0.001).
Twenty-five percent (25%) of patients given a single oral dose of PTI-555 90mg achieved complete pain relief within eight hours of dosing, compared to just three percent (3%) of patients given a single 90mg dose of oral morphine sulfate (p<0.04).
PTI-555 was well tolerated and was not associated with any reported serious adverse events, either during the trial or the subsequent follow-up period. The percentage of patients reporting any drug related adverse events during the 24 hours following dosing was approximately the same in the two drug groups. Certain nervous system conditions, such as somnolence, fatigue and euphoria, occurred less frequently in the PTI-555 treatment group.
PTI-555 Morphine Placebo
Any adverse event 86% 93% 29%
Vomiting 46% 50% 3%
Somnolence 18% 23% 3%
Fatigue 4% 13% 0%
Euphoria 0% 7% 0%
Pain Therapeutics, Inc. is holding a conference call to discuss these results and its clinical program regarding PTI-555/501 on October 5, 2001 at 10:00 a.m. Pacific Time/1:00 p.m. Eastern Time. Domestic and international listeners may access the call by dialing 303-262-2175. Participants may also join the call over the Internet on the Shareholder page of the Company's website at www.paintrials.com. If unable to participate in the live conference call, a telephone replay will be available through October 12, 2001 by dialing 303-590-3000, code 400845. A replay of the conference call will also remain on the website for 30 days.
About Opioid Painkillers
Opioid painkillers are a $3 billion market in the United States and account for over five percent of all drug prescriptions. Opioids are drugs derived from the poppy plant. The clinical use of opioids to treat severe pain is widely accepted throughout the world. Despite their widespread use, opioid drugs have debilitating effects that limit their usefulness at all doses. Chronic use may lead to tolerance, dependence, addiction or medical abuse. As a result, some patients prefer to suffer through pain rather than to endure the adverse effects of opioid drugs. Effective pain management is a growing and unmet need in the United States. For example, according to the National Institutes of Health, over 40 million Americans are unable to find relief from their pain.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is an emerging leader in the area of pain management. The Company is developing novel painkillers that address the deficiencies of oxycodone, morphine and other opioid painkillers that are widely used in clinical medicine. The Company is currently in Phase II clinical trials with several proprietary painkillers. Pain Therapeutics has headquarters in South San Francisco, California and is traded on Nasdaq under the symbol PTIE. For additional information, please visit the Company's web site at www.paintrials.com.<<
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Since when is euphoria an adverse event? Since March 2000, I suppose. So this is just the kind of medication we investors need. BLUE HP wishes it had the cash, pending your opinion, or that of other biofreaks. Edit: If I'm remembering my p numbers correctly, the total relief results are almost statistically significant. As the company says, the trial design with multiple cohorts tends toward higher p numbers, so this would imply a slam dunk in PIII, IMO, bwdik.
Cheers, Tuck |
