VIVUS Announces Positive Results From Phase 2 Study of Qnexa in Obstructive Sleep Apnea
Qnexa Treatment Results in 69% Reduction in Sleep Apnea Events
MOUNTAIN VIEW, Calif., Jan. 7 /PRNewswire-FirstCall/ -- VIVUS,
Inc. (NASDAQ:VVUS) today announced positive results
from a phase 2 study evaluating the safety and efficacy of
Qnexa®, an investigational drug, for the treatment of
obstructive sleep apnea (OSA). VIVUS recently completed phase 3
development of Qnexa for the treatment of obesity and submitted a
New Drug Application (NDA) to the FDA for that indication. The
study announced today demonstrated statistically significant
improvement in the apnea/hypopnea index ("AHI" - a measure of the
severity of sleep apnea) in patients with OSA treated with Qnexa
for 28 weeks. Qnexa-treated patients also experienced significant
weight loss, improvements in blood pressure, and overnight blood
oxygen levels. OSA is a sleep-related breathing disorder that
involves a decrease or complete halt in airflow despite an ongoing
effort to breathe. OSA is associated with an increased risk of
hypertension, diabetes, stroke, sudden cardiac death and all-cause
mortality. Approximately 18 million Americans have sleep
apnea.
"Obstructive sleep apnea is a serious condition with recognized
cardiovascular and metabolic consequences, including premature
death. Current treatment approaches are limited to devices or
surgery," stated Leland Wilson, chief executive officer of VIVUS.
"We know that substantial weight loss can significantly improve
sleep apnea. These phase 2 data suggest that Qnexa, if approved for
this indication, may be a promising treatment for OSA. We have
submitted the study results for presentation at a scientific
meeting. We also look forward to meeting with the FDA to discuss
the results of this study and to determine the regulatory path for
approval."
Currently, there are no approved pharmacologic treatments for
OSA.
The apnea/hypopnea index is the standard measure of OSA
severity, indicating the number of apnea/hypopnea events per hour
of sleep. The phase 2 study (OB-204) was a single-center,
randomized, double-blind, placebo-controlled parallel group trial
including 45 obese men and women (BMI 30 to 40 kg/m2, inclusive),
30 to 65 years of age. Patients enrolled were diagnosed with OSA
based on an AHI greater than or equal to 15 (moderate to severe) at
baseline. In addition to receiving active or placebo drug, all
patients were provided with an intensive lifestyle modification
program.
Highlights of the study include:
-- Patients treated with Qnexa for 28 weeks had a 69% reduction in sleep
apnea events
-- Qnexa treatment reduced the number of apnea/hypopnea events from a
mean of 46 events per hour of sleep to 14 -- compared to placebo
patients with a reduction from a mean 44 events per hour of sleep
to 27 (ITT-LOCF p less than or equal to 0.001 active vs. placebo)
-- Qnexa treated patients lost 10.2% body weight, or 23.8 lbs in 28 weeks
-- compared to 4.3% for placebo patients, or 10.4 lbs, (ITT-LOCF
p<0.001 active vs. placebo)
-- Systolic blood pressure was reduced by 15 mm Hg in the Qnexa group
from a mean of 138 mm Hg at baseline (ITT-LOCF p<0.04 active vs.
placebo)
-- Mean overnight oxygen saturation was significantly improved in Qnexa
patients (p<0.014 active vs. placebo)
-- Qnexa treatment was well-tolerated with no serious adverse events
reported in the Qnexa arm; the most common side-effects were dry
mouth, altered taste and sinus infection
"People often underestimate the extent and significance of
obstructive sleep apnea, and the potentially deadly effects it can
have for those who suffer from repetitive cessation of breathing
during sleep. Appropriate diagnosis and treatment of OSA, which is
associated with a six-fold increase in mortality, is critical for
patients to reduce their risk," stated David Winslow, MD,
president, Kentucky Research Group, Chest Medicine Associates,
P.S.C., Louisville and the study's primary investigator. "These
positive Qnexa data are encouraging, as there are currently no drug
treatments available for the condition. Having a safe and effective
oral pharmacologic therapy available to treat OSA would be a
welcome addition for patients."
Sleep apnea is one of the leading co-morbidities associated with
obesity and research has shown that weight loss can improve OSA.
Qnexa may improve OSA through other mechanisms in addition to
weight loss. Additional studies are planned to define those
mechanisms.
These data follow the December 2009 submission of our new drug
application to the U.S. Food and Drug Administration for Qnexa for
the treatment of obesity, including weight loss and maintenance of
weight loss, in patients who are obese or overweight with
co-morbidities such as hypertension, type 2 diabetes, dyslipidemia
or central adiposity. In September 2009, VIVUS announced the
successful completion of the phase 3 program for Qnexa, including
the recently announced results from the two pivotal, year-long
phase 3 studies, EQUIP and CONQUER. In these trials, patients
treated with all three doses of Qnexa achieved significant percent
and categorical weight loss compared to placebo and met regulatory
requirements for weight loss products as defined in the current FDA
Guidance for Developing Products for Weight Management. Patients
treated with Qnexa also had significant dose-related improvements
in a variety of secondary endpoints including reductions in
cardiovascular and metabolic risk factors.
About the OB-204 Study
This phase 2 study (OB-204) was a single-center, randomized,
double-blind, placebo-controlled parallel group trial including 45
obese men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65 years
of age with OSA (AHI greater than or equal to 15 at baseline), who
had not been treated with, or who were not compliant with
continuous positive airway pressure (CPAP) within three months of
screening. Patients were randomized to placebo or full-dose Qnexa.
Patients underwent a four-week dose titration followed by 24 weeks
of additional treatment. All patients were also provided with an
intensive lifestyle modification program focusing on diet and
exercise. Overnight polysomnography was performed at baseline, Week
8 and Week 28. The primary endpoint was the change in AHI between
baseline and Week 28; secondary endpoints included weight loss,
oxygen saturation and changes in blood pressure.
About Obstructive Sleep Apnea (OSA)
Obstructive sleep apnea (OSA) is a sleep-related breathing
disorder that involves a decrease or complete halt in airflow
despite an ongoing effort to breathe. It is a common yet serious
disorder characterized by repeated pauses in breathing during the
sleep cycle. Approximately 18 million Americans are afflicted with
OSA, though an estimated 90% of patients remain undiagnosed or
untreated. Studies have identified a causal relationship between
OSA and a number of cardiovascular and metabolic diseases including
hypertension, diabetes, stroke, congestive heart failure and sudden
cardiac death. Patient compliance can be an issue in treating OSA
and can limit the effectiveness of currently available treatments
which include lifestyle changes, continuous positive airway
pressure (CPAP) devices and surgery.
Note to Investors
As previously announced, VIVUS will hold a conference call to
discuss these results today, January 7, 2010, beginning at 8:30
a.m. Eastern Time. You can listen to this call by dialing toll free
1-888-806-6202 or outside the U.S. 1-913-312-6680. 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 Qnexa
Qnexa (Q-NEX-uh) is an investigational drug being developed to
address weight loss, type 2 diabetes and obstructive sleep apnea.
Qnexa is a once-a-day, proprietary, oral, controlled-release
formulation of low dose phentermine and topiramate, which is
believed to address both appetite and satiety - the two main
mechanisms that impact eating behavior - in one capsule. In phase 2
and 3 clinical data to date, Qnexa has demonstrated significant
weight loss, glycemic control, and improvement in cardiovascular
risk factors.
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®, has completed phase 3 clinical trials for
the treatment of obesity and an NDA was submitted to the FDA in
December 2009. Qnexa is also in phase 2 clinical development for
the treatment of type 2 diabetes and obstructive sleep apnea. In
the area of sexual health, VIVUS is in phase 3 development with
avanafil, a potentially best-in-class PDE5 inhibitor for the
treatment of erectile dysfunction, 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; or Investor Relations: Brian Korb of The Trout
Group,
+1-646-378-2923; or Media Relations: Dan Budwick of Pure
Communications,
Inc., +1-973-271-6085
Web Site: http://vivus.com/
Posted: January 2010
