Apparently Senetek (Invacorp) has a little more "gold standard" to offer Padma-Nathan than Vivus.
Subj: Doctors Expect Oral Therapies To Dramatically Expand Erectile Dysfunction ED) Ma
Date: 97-11-10 14:14:03 EST
From: AOL News
BCC: Zebra 365
NEW YORK CITY, Nov. 10 /PRNewswire/ -- "Oral therapies, certainly, will
revolutionize treatment of erectile dysfunction (ED)," says Harin Padma-
Nathan, M.D., associate clinical professor of urology at the University of
Southern California's School of Medicine in Los Angeles and director of The
Male Clinic in Santa Monica, Calif. "Eventually, nearly all ED patients will
be offered oral treatment as a first-line therapy."
Those who fail oral therapy will then progress to injection therapy, "the
gold standard," says Dr. Padma-Nathan. He told a group of science writers who
convened recently at the National Institutes of Health (NIH) in Washington,
D.C., that Senetek PLC's (Nasdaq: SNTKY) Invicorp, an autoinjectable ED drug
in development, "promises to continue the vitality of injection therapy in
this field" -- a very large market, he says.
Healthcare consultants Mehta and Isaly, in their June 1997 report, "Stiff
Competition Ahead in the Growing Erectile Dysfunction Market", conservatively
estimate that the number of men suffering from ED in the United States, Europe
and Japan could be as high as 50 million. "From less than $500 million in
1996, made up of mostly ineffective treatments, we estimate a $3.8 billion
market for erectile dysfunction in 2003," says the Mehta and Isaly report.
A number of analysts have identified at least four drugs that may be the
biggest beneficiaries of market expansion if they are eventually approved for
marketing by the FDA, including three oral drugs -- Pfizer's Viagra
(sildenafil), TAP Holdings' apomorphine, Zonagen's Vasomax (phentolamine) --
and Senetek's autoinjectable drug, Invicorp. (Where's MUSE??)
FDA approval of one or more oral drugs will be the key to major expansion
of the ED market, several analysts say. Other products contributing to the
growth of the market may be: Pharmacia & Upjohn's Caverject (alprostadil), an
injectable ED therapy launched in September 1995; and Schwarz Pharma's Edex,
an injectable alprostadil product that received FDA approval in June.
The term "erectile dysfunction" is a recent one, replacing the word
"impotence", though both terms refer to the same disease: an inability to
achieve erection sufficient for sexual intercourse.
Some 140 million men worldwide suffer from ED. The market can be divided
between two different causes: psychogenic and organic. Mehta and Isaly
estimate the split to be about 20 percent psychogenic, 80 percent organic.
Organic-based ED can be further broken down into: mild erectile dysfunction
(30 %), moderate (50%), and severe (20%).
According to physicians, only about 10 percent of men who have ED seek
treatment today. The problem is not that ED treatments are ineffective. More
often, the stumbling blocks appear to be ignorance that effective ED
treatments are in fact available, or embarrassment about pursuing ED
treatment, or the distastefulness associated with current therapeutic
alternatives.
"Oral drugs will be the first choice of patients once they are on the
market due to the non-invasive nature of administration," according to Mehta
and Isaly. "(However) data from various clinical trials suggest that oral
drugs do not work across the range of erectile dysfunction categories, and
some of their side effects may limit widespread use."
By 2000, industry analysts expect that at least three oral drugs --
sildenafil, apomorphine and phentolamine -- may be on the market serving most,
if not all, of the psychogenic- and some of the mild organic-based ED markets.
There is debate as to which oral drugs will lead the market when they are
approved.
While most physicians agree that the oral drugs, if approved, will evolve
into first-line therapies, David Ferguson, M.D., Ph.D., a clinical
pharmacology specialist and a consultant to the drug industry in designing
clinical trials for ED drug companies, believes that doctors will probably try
different treatments, starting with mild ED therapies and moving to stronger
ones, until their patients find one that is effective.
Injectables probably will remain the strongest pharmaceutical therapies
and likely will be the preferred option after a patient tries and fails oral
delivery methods. (I'm sorry but this is just where MUSE should be interjected. Zebra) Two prostaglandin injectable therapies already are on the
market: Pharmacia & Upjohn's Caverject and Schwarz Pharma's Edex.
Invicorp, the autoinjectable ED therapy from Senetek, could very likely
become the leading second-line therapy, says Dr. Ferguson. In addition to its
reported 81 percent overall efficacy in clinical trials involving 718 European
men, other Invicorp advantages, he says, are its autoinjector, which makes
injections easy to perform, and the lack of a burning sensation that some men
experience with prostaglandin therapies.
Geoffrey Hackett, M.D., who founded an ED clinic near London three years
ago and has been part of clinical trials using both Viagra and Invicorp, is
currently prescribing Invicorp for about 70 percent of his ED patients (while
awaiting regulatory approval, Invicorp is available on a "named-patient" basis
in the U. K.). He believes Invicorp presents fewer problems than other ED
injection therapies because its autoinjector is easy to use and a patient
never sees, nor barely feels, the needle.
Also, says Dr. Hackett, Invicorp avoids the penile pain that he has
witnessed in approximately 30 percent of Caverject users. While he, too,
believes patients will prefer oral over injectable therapies if they work, he
notes that Viagra is less spontaneous than Invicorp because it requires at
least one hour to become effective, compared to about five minutes -- with
sexual stimulation -- for Invicorp.
"With its favorable side-effect profile, efficacy in organic erectile
dysfunction, rapid onset of erection after stimulation, ability to induce
erection up to two-and-one-half hours after administration, and natural
termination of erection after ejaculation," says Dr. Hackett, "Invicorp should
have significant market potential and certainly stands the best chance to
become the second-line therapy of choice after oral therapies."
Dr. Ferguson is even more bullish about Invicorp. "Given the substantial
data from European clinical studies, it appears to me that Invicorp ought to
be able to seize the entire injectable segment of the ED market, which I
believe will be about a 25 percent share," he says.
Ridwan Shabsigh, M.D., assistant professor of urology with Columbia
University's College of Physicians and Surgeons and director of the Sexual
Dysfunction clinic at Columbia Presbyterian Medical Center's N.Y. Male
Reproductive Center, concurs with Dr. Ferguson, adding that, "Invicorp likely
will continue the role of injectable ED therapies as the gold standard.
Invicorp's clinical data are extensive and very impressive."
At this time, Senetek's Invicorp therapy is not approved for marketing
anywhere in the world. Senetek expects regulatory approval of Invicorp in
Europe either by year-end or in the first quarter of 1998. It expects to
submit an NDA (New Drug Application) to the FDA by year's end.
Visit Senetek's Web site on the Internet -- senetekplc.com
To receive previous Senetek news releases by fax, call PR Newswire's
"Company News On Call" -- 800-758-5804, extension 115015.
AHHH Dr. PADMA-NATHAN, you presented the findings below only 15 months ago, how soon you forget..... From the Vivus Web site:
Abstract Presented by Dr. Harin Padma-Nathan
at the Western Section of the American Urological Association Annual Meeting
July 31, 1996
RESTORATION OF ERECTILE FUNCTION BY TRANSURETHRAL ALPROSTADIL IMPROVES THE QUALITY OF LIFE FOR PATIENTS AND THEIR PARTNERS. Harin Padma-Nathan, Ronald G. Anderson, Stanley A. Brosman, Robert G. Ferrigni, Fred E. Govier, Richard F. Labasky, Tom F. Lue, Ira D. Sharlip, Gary M. Stack, Emil A. Tanagho, Jay M. Young, Christy Cowley, Neil Gesundheit, Craig A. Peterson, Alfred P. Spivack, Darby E. Stephens, Peter Y. Tam, Virgil A. Place, and the VIVUS-MUSE Study Group, Menlo Park, CA.
Previous studies have shown that alprostadil, delivered transurethrally, can restore erections and sexual intercourse in many men with chronic erectile dysfunction. We have now studied the effect of treatment and restoration of sexual function on Quality of Life in couples during a three-month, double-blind, placebo-controlled trial.
Methods. We studied 996 adult men (age: 30-84; mean 62) with chronic organic erectile dysfunction (mean duration: 48 months) who were in a stable, heterosexual, monogamous relationship and responded adequately to transurethral alprostadil during in-clinic titration. Patients were randomized to home therapy for three months with either active drug (at their titrated dose) or placebo (double-blind). Patients and partners each completed Quality of Life questionnaires before, during, and after the study. Participants indicated their response to each question on a 0-100 scale. The questionnaire included questions about anxiety, self-esteem, and mood (depression), which were analyzed as an "Emotional Well-Being" domain. Questions about the couple's sexual and nonsexual relationship were analyzed as a "Relationship With Partner" domain.
Results. All couples had been unable to engage in sexual intercourse for at least 3 months preceding enrollment. During home treatment, 64.9% of patients on alprostadil vs. 18.6% of those on placebo reported intercourse at least once (p < 0.001). Couples randomized to active drug or placebo had comparable Quality of Life scores at baseline. In patients who responded to active medication, there was a significant improvement in the "Emotional Well-Being" domain compared to those on placebo (p < 0.004). Similarly, there was a significant improvement in the "Relationship With Partner" domain for responders and for partners of responders compared to placebo (p < 0.001 for each). There was no change in either the active or placebo group in the "Emotional Well-Being" domain of the partner.
Quality of Life Domains.....................Baseline.... Final....... p-value
Emotional Well-Being of Patients
Active Drug (Responders).................... 64.8........ 68.6........ < 0.004
Placebo .............................................65.7........ 66.9
Patient's Relationship with Partner
Active Drug (Responders).................... 58.6........ 63.8........ < 0.001
Placebo............................................. 58.1........ 56.0
Partner's Relationship with Patients
Active Drug (Responders).................... 56.4........ 62.7........ < 0.001
Placebo............................................. 55.9........ 54.6
Summary. Restoration of sexual intercourse by transurethral alprostadil is associated with improvement in several important Quality of Life domains: "Emotional Well-Being" for patients and "Relationship With Partner" for both the patient and his partner.
For more information, contact VIVUS at: product@vivus.com. For medical information, contact VIVUS at: medical@vivus.com. Please include your mailing address so that information can be sent to you.
Alternatively, you may call our toll-free informational hot-lines:
If you are a patient, call: 1-888-367-MUSE
If you are a healthcare professional, call: 1-888-345-MUSE
Yes, it is time to start the MUSE PR machine and the theme is: I'M HERE FOR THE DURATION !!
Zebra |
