VIVUS Reports Data Supporting the Cardiovascular Safety of Qsymia®
August 27 2018 - 7:30AM
-Retrospective analysis presented at the
34th International Conference on Pharmacoepidemiology &
Therapeutic Risk Management-
VIVUS, Inc. (Nasdaq: VVUS; the “Company”), a biopharmaceutical
company, has reported encouraging data from a retrospective
analysis evaluating the cardiovascular safety of Qsymia®
(phentermine and topiramate extended-release) capsules CIV.
Results show that the risk of major adverse cardiovascular
events (MACE) trended lower in patients taking Qsymia compared with
similar patients who were not taking Qsymia. The results were
presented yesterday in a poster at the 34th International
Conference on Pharmacoepidemiology & Therapeutic Risk
Management, which took place in Prague, Czech Republic, August
22-26.
“The results of this retrospective analysis add
to the body of data demonstrating that Qsymia does not increase the
risk of MACE,” said John Amos, Chief Executive Officer at
VIVUS. “We continue to believe that Qsymia provides patients
with significant benefits as a platform for managing body mass
index, and our ongoing dialogue with the U.S. Food and Drug
Administration includes a label modification request to allow for
the safe and effective short-term utilization of Qsymia while
significantly reducing or eliminating the requirement for
conducting a cardiovascular outcomes study.”
Results of the study were presented in a poster
titled “Cardiovascular Safety of Phentermine and Topiramate in a
United States Claims Database,” (Abstract 983/118). The study was a
retrospective cohort analysis conducted in MarketScan Commercial
Claims and Medicare Supplemental data. The study evaluated MACE
rates during periods of exposure to Qsymia, generic phentermine and
topiramate combinations (PHEN/TPM) and phentermine (PHEN) or
topiramate (TPM) alone, and compared each of these to MACE rates
during unexposed periods in former users of these drugs. MACE was
defined as a composite of hospitalization for acute myocardial
infarction (AMI), stroke, or in-hospital cardiovascular-related
death as determined via discharge status and ICD-9-CM
diagnoses.
Propensity scores were calculated to adjust for
differences in cardiovascular risk factors among the cohorts.
Propensity score-adjusted analyses showed that MACE risk trended
lower with current Qsymia and PHEN/TPM use compared with the
unexposed cohort. Compared to the unexposed cohort, MACE risk was
also lower with current PHEN use and higher with current TPM use.
The study authors note that the small number of events that
occurred during exposure to Qsymia and PHEN/TPM produced
considerable statistical uncertainty in the analysis of these
cohorts.
About QsymiaQsymia is approved
in the United States and is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management in adults with an initial body mass index (BMI)
of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater
(overweight) in the presence of at least one weight-related medical
condition such as high blood pressure, type 2 diabetes, or high
cholesterol.
The effect of Qsymia on cardiovascular morbidity
and mortality has not been established. The safety and
effectiveness of Qsymia in combination with other products intended
for weight loss, including prescription and over-the-counter drugs,
and herbal preparations, have not been established.
Important Safety
InformationQsymia (phentermine and topiramate
extended-release) capsules CIV is contraindicated in pregnancy; in
patients with glaucoma; in hyperthyroidism; in patients receiving
treatment or within 14 days following treatment with monoamine
oxidase inhibitors; or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive
ingredients in Qsymia.
Qsymia can cause fetal harm. Females of
reproductive potential should have a negative pregnancy test before
treatment and monthly thereafter and use effective contraception
consistently during Qsymia therapy. If a patient becomes pregnant
while taking Qsymia, treatment should be discontinued immediately,
and the patient should be informed of the potential hazard to the
fetus.
The most commonly observed side effects in
controlled clinical studies, 5% or greater and at least 1.5 times
placebo, include paraesthesia, dizziness, dysgeusia, insomnia,
constipation, and dry mouth.
About VIVUSVIVUS is a
biopharmaceutical company committed to the development and
commercialization of innovative therapies that focus on advancing
treatments for patients with serious unmet medical needs. For
more information about the Company, please visit www.vivus.com.
Forward-Looking
StatementsCertain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to the timing of initiation and completion of the
post-approval clinical studies required as part of the approval of
Qsymia by the U.S. Food and Drug Administration, or FDA; risks and
uncertainties related to the response from FDA to any data and/or
information relating to post-approval clinical studies required for
Qsymia; risks and uncertainties related to our ability to work with
FDA to significantly reduce or remove the requirements of the
clinical post-approval cardiovascular outcomes trial, or CVOT;
risks and uncertainties related to the impact of the indicated uses
and contraindications contained in the Qsymia label and the Risk
Evaluation and Mitigation Strategy, or REMS, requirements; risks
and uncertainties related to the fact that we may be required to
provide further analysis of previously submitted clinical trial
data; and risks and uncertainties related to our dialog with the
European Medicines Agency, or EMA, relating to real world safety
data for Qsymia and the resubmission of the marketing authorization
application, and the assessment by the EMA of the marketing
authorization application and the real world safety data. These
risks and uncertainties could cause actual results to differ
materially from those referred to in these forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. Investors should read the risk
factors set forth in VIVUS’ Form 10-K for the year ended December
31, 2017 as filed on March 14, 2018, and as amended by the Form
10-K/A filed on April 26, 2018, and periodic reports filed with the
Securities and Exchange Commission. VIVUS does not undertake
an obligation to update or revise any forward-looking
statements.
VIVUS,
Inc. |
Investor
Relations: Lazar Partners |
Mark Oki |
David Carey |
Chief Financial
Officer |
Managing Director |
oki@vivus.com |
dcarey@lazarpartners.com |
650-934-5200 |
212-867-1768 |
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