VIVUS Announces Positive Results From Phase 3 Study of Avanafil in Erectile Dysfunction; Data Demonstrate Robust Efficacy, Favorable Side-Effect Profile
Results Underscore Differentiating Profile; Indicate Significant Market Opportunity for Avanafil
MOUNTAIN VIEW, Calif., Nov. 18 /PRNewswire-FirstCall/ -- VIVUS,
Inc. (NASDAQ:VVUS) today announced positive results
from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety
and efficacy of avanafil, an investigational drug candidate for the
treatment of erectile dysfunction (ED), in 646 patients. The REVIVE
study met all primary endpoints across the three doses studied by
demonstrating statistically significant improvement in erectile
function as measured by the Sexual Encounter Profile (SEP) and
improvements in the International Index of Erectile Function (IIEF)
score. The pivotal study, conducted under a Special Protocol
Assessment with the U.S. Food and Drug Administration (FDA), also
demonstrated successful intercourse in 30 minutes or less, and a
favorable side-effect and safety profile.
"Erectile dysfunction is a significant problem among more than
half of all men over the age of 40. While sales of currently
available ED therapies exceed $3.8 billion a year, persistent
switching by patients suggests that patients are less than
satisfied with current therapies," stated Leland Wilson, chief
executive officer of VIVUS. "These phase 3 avanafil data not only
confirm the robust efficacy we've seen in earlier trials, but
potentially differentiate avanafil from other PDE5 inhibitors when
it comes to side effects and time-to-onset of efficacy. We are
confident that avanafil can effectively compete in the oral ED
therapy market."
Highlights of the study include:
-- Nearly 80% of sexual attempts among patients on the 200 mg dose of
avanafil had erections sufficient for intercourse (SEP2)
-- Full efficacy, as measured by successful intercourse, was reported by
avanafil patients in 30 minutes or less
-- Full efficacy was maintained for all doses across multiple time points
from 30 minutes to beyond six hours
-- All FDA-defined primary endpoints were met across all three doses of
avanafil
-- Avanafil was well tolerated as demonstrated by a high retention rate
(85%)
-- There were no drug-related serious adverse events in the study
-- Avanafil patients had low reports of common PDE5i side effects
"Many patients living with chronic ED become frustrated by the
occasional treatment-limiting side effects associated with
currently available therapies. Patients often switch therapies in
search for an improved experience," stated LeRoy Jones, MD,
Clinical Associate Professor, Urology, University of Texas Health
Science Center, San Antonio and an avanafil trial investigator.
"The efficacy and safety data for avanafil underscore the potential
role this next-generation PDE5 inhibitor may play in the lives of
the millions of men living with ED, searching for new treatment
options."
Dr. Jones added, "Another important consideration of patients is
how quickly their ED therapy works; these data suggesting that
avanafil achieves a full effect in 30 minutes or less, with a
window of opportunity for intercourse extending beyond six hours,
would be a welcome option for ED treatment."
The REVIVE study was a randomized, double-blind,
placebo-controlled efficacy and safety study that evaluated three
doses of avanafil in men with a history of general ED. The results
of the phase 3 study showed:
-- Patients achieved an overall improvement in erectile function, as
measured by improvement in the International Index of Erectile
Function (IIEF). IIEF scores range from 0-30 and measure the severity
of erectile dysfunction as follows: severe dysfunction is less than or
equal to 10; moderate is 11-16; and mild/minimal is 17-25. Results of
the study were:
Baseline End of Treatment
-------- ----------------
Placebo 12.4 15.3
Avanafil 50 mg 12.7 18.1
Avanafil 100 mg 12.6 20.9
Avanafil 200 mg 12.7 22.2
(p
The most commonly reported side effects in patients taking
avanafil (all doses combined) included headache (7.0% vs. 1.2%
placebo), flushing (4.6% vs. 0% placebo) and nasal congestion (2.3%
vs. 1.2%); there were no reports of visual disturbances such as
"blue vision."
VIVUS had previously completed a phase 1 thorough QT
prolongation (TQT) study evaluating 100 mg and 800 mg of avanafil.
The study was successfully completed with no concern associated
with QT prolongation.
"The high selectivity and rapid peak drug concentrations of
avanafil make for a very attractive product profile, which is
potentially associated with fewer side effects and faster onset of
full efficacy - two attributes preferred by men looking for faster
and more tolerable options. Full efficacy was seen in 30 minutes or
less, and based on patient reported outcomes, the duration of full
effect lasted beyond six hours. Based on these results, we believe
that avanafil can be positioned as a true on-demand therapy for
patients looking for a rapid response," said Wesley Day, PhD, vice
president clinical development of VIVUS. "We're pleased with the
promising results demonstrated with avanafil, and look forward to
further advancing our clinical program toward filing an NDA for
avanafil in late 2010 or early 2011."
Mr. Wilson added, "These compelling data for avanafil follow the
recent positive phase 3 obesity data for QNEXA, for which we expect
to file an NDA before the end of the year, placing VIVUS in the
fortunate position of having two late-stage products addressing
large markets with significant unmet needs and near-term regulatory
and data milestones on the horizon. These assets, combined with our
solid cash position, provide VIVUS with significant momentum as we
end the year and look ahead towards 2010."
About the Study
REVIVE (TA-301) was a randomized, double-blind,
placebo-controlled phase 3 study of avanafil in 646 men with a
history of generalized ED for at least six years; 72% of study
participants had tried at least one other ED treatment. Patients
underwent a four-week, non-treatment run-in period followed by 12
weeks of treatment with one of three doses of avanafil: 50mg, 100
mg and 200mg or placebo. Patients were instructed to attempt sexual
intercourse 30 minutes after taking avanafil, with no restrictions
on food or alcohol consumption. The primary endpoints of the study
were improvement in erectile function as measured by the Sexual
Encounter Profile (SEP) and improvements in the International Index
of Erectile Function (IIEF) score; secondary endpoints included
patient satisfaction with erections and with sexual experience. The
phase 3 study was conducted under a Special Protocol Assessment
with the U.S. FDA.
REVIVE is the first of four phase 3 avanafil trials. Additional
phase 3 studies include treatment in diabetic males with ED
(REVIVE-Diabetes, TA-302) and in males with ED following a
post-radical prostatectomy (TA-303), each with a treatment period
of approximately 16 weeks. In March of this year, VIVUS initiated
an open-label safety study (TA-314) evaluating the long-term safety
and tolerability of avanafil as part of its path toward NDA filing.
TA-314 is being conducted over one year in approximately 600
patients across 40 U.S. centers; patients completing either the
12-week REVIVE or REVIVE-Diabetes studies are eligible to
participate in TA-314. Results of the study are expected to be
available by late-2010.
In total, the phase 3 avanafil clinical program will enroll
approximately 1,300 patients.
Note to Investors
As previously announced, VIVUS will hold a conference call to
discuss these results today, November 18, 2009, beginning at 8:30
a.m. Eastern Time. You can listen to this call by dialing toll free
1-800-776-0853 or outside the U.S. 1-913-312-0980. A 30-day archive
of the call can be accessed at http://ir.vivus.com/.
To access the webcast of this event, please visit: VIVUS'
Investors site at http://ir.vivus.com/events.cfm. Replay will also
be available on demand from the website at the conclusion of the
program.
About Avanafil
Avanafil is a next-generation, highly selective oral
phosphodiesterase type 5 (PDE5) inhibitor therapy being
investigated for the treatment of ED. Studies to date have
demonstrated that avanafil has a fast onset of action, with
activity apparent in 30 minutes or less after administration. The
unique profile of avanafil suggests that the compound may be more
selective than other PDE5 inhibitors, potentially resulting in
lower incidence of the side effects most commonly associated with
PDE5 inhibitor therapies.
About Erectile Dysfunction (ED)
Erectile Dysfunction (ED) is defined as the inability to attain
and maintain an erection sufficient for sexual intercourse.
According to the Massachusetts Male Aging Study (MMAS), ED affects
an estimated 52 percent of men between the ages of 40 and 70. The
prevalence of ED increases with age and can be affected by a
variety of factors, including certain medications such as
anti-hypertensives and histamine receptor antagonists; lifestyle,
such as tobacco or alcohol use; diseases, including diabetes and
cardiovascular conditions; and spinal cord injuries.
About VIVUS
VIVUS is a biopharmaceutical company developing innovative,
next-generation therapies to address unmet needs in obesity,
diabetes and sexual health. The company's lead product in clinical
development, Qnexa(TM), has recently completed phase 3 clinical
trials for the treatment of obesity. Qnexa is also in phase 2
clinical development for the treatment of type 2 diabetes. In the
area of sexual health, VIVUS is in phase 3 development with
avanafil, a potentially best-in-class PDE5 inhibitor, and in phase
2 development of Luramist(TM) for the treatment of hypoactive
sexual desire disorder (HSDD) in women. MUSE® (alprostadil), a
first generation therapy for the treatment of ED, is already on the
market and generating revenue for VIVUS. For more information about
the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimated" and "intend," among others. These forward-looking
statements are based on VIVUS' current expectations and actual
results could differ materially. There are a number of factors that
could cause actual events to differ materially from those indicated
by such forward-looking statements. These factors include, but are
not limited to, substantial competition; uncertainties of patent
protection and litigation; uncertainties of government or third
party payer reimbursement; reliance on sole source suppliers;
limited sales and marketing efforts and dependence upon third
parties; risks related to the development of innovative products;
and risks related to failure to obtain FDA clearances or approvals
and noncompliance with FDA regulations. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products. There
are no guarantees that future clinical studies discussed in this
press release will be completed or successful or that any product
will receive regulatory approval for any indication or prove to be
commercially successful. VIVUS does not undertake an obligation to
update or revise any forward-looking statement. Investors should
read the risk factors set forth in VIVUS' Form 10-K for the year
ended December 31, 2008 and periodic reports filed with the
Securities and Exchange Commission.
CONTACT:
VIVUS, Inc. Investor Relations: The Trout Group
Timothy E. Morris Brian Korb
Chief Financial Officer 646-378-2923
650-934-5200 Media Relations: Pure Communications, Inc.
Dan Budwick
973-271-6085
Source: VIVUS, Inc.
CONTACT: Timothy E. Morris, Chief Financial Officer, VIVUS,
Inc.,
+1-650-934-5200; Investors, Brian Korb, The Trout Group,
+1-646-378-2923; or
Media, Dan Budwick, Pure Communications, Inc., +1-973-271-6085,
both for
VIVUS, Inc.,
Web Site: http://ir.vivus.com/
