VIVUS FDA Approval of Qsymia Expands the Obesity Customer Base

Health and Healthcare

Published: April 16, 2013 3:21 pm

Last Updated: March 26, 2020 7:27 pm

VIVUS, Inc. (NASDAQ: VVUS) has just secured Food and Drug Administration approval of an amendment and modification to the Risk Evaluation and Mitigation Strategy for its weight-loss drug Qsymia. With a recent study published about the fattest cities in America the timing of this approval may seem somewhat coincidental. We have a different take here than it just being good news.

For starters, the approved amendment was submitted back in October 2012 and it will now allow Qsymia to be dispensed through certified retail pharmacies as well as through the existing network of certified mail-order pharmacies. 24/7 Wall St. views this is a net positive event, but with the drug still being slowly adopted it may be just an add-on event as far as analysts are concerned.

By adding certified retail pharmacies to the Qsymia network, the goal is to reduce the prescribing burden for doctors as well as the waiting times for patients who want to start therapy to treat their obesity. The company showed that Qsymia certified mail-order pharmacies will remain, but today’s news is expected to expand retail availability.

VIVUS said that the availability at certified retail pharmacies can be expected in the next 90 days and healthcare providers and patients should continue to utilize the current certified mail-order network until further notice is given. One hope is that VIVUS can benefit from a fresh study covered from the Center for Disease Control which could offer a big boost to obesity drugs.

VIVUS shares were briefly up about 8% and hit a high of $12.35 today but the stock is up only by 2.6% at $11.45 in the final hour of the day. The stock’s 52-week range was $9.86 to $31.21 and the Thomson Reuters consensus analyst target price is $18.04.

Peter Tam, president of VIVUS, said,

“With FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system. Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice. We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage.”

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