Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



FDA Makes Obesity Drug Available to More Americans

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

VIVUS (NASDAQ: VVUS  ) took a much-needed step toward accelerating sales of its obesity drug Qsymia today when the Food and Drug Administration approved a modification of the company's Risk Evaluation and Mitigation Strategy, or REMS, to allow sales of the drug in retail pharmacies.

REMS are established by the FDA when drugs are potentially harmful, especially if they're used in the wrong way. They can be fairly mild -- including a patient brochure, for instance -- or they can make doctors and patients jump through hoops to get the drug, such as requiring training for doctors or enrolling patients in a registry to track side effects.

In Qsymia's case, the drug has the potential to cause birth defects if taken by pregnant women. In addition to a medication guide, patient brochure, and a voluntary health care provider training to get the word out that women should avoid getting pregnant while on the drug, the FDA told VIVUS that it would only be able to sell Qsymia at mail-order pharmacies.

But by the time Qsymia was approved, the agency had already backed down from its hard-lined stance, telling the company that it was open to the idea of selling the drug through retail pharmacies. VIVUS applied to change the REMS to include certified retail pharmacies capable of following the rest of the REMS program, which the agency approved today.

The expansion is bad news for Arena Pharmaceuticals (NASDAQ: ARNA  ) and Eisai, which will launch their competing obesity drug, Belviq, as soon as the DEA decides on its potential for abuse. It would have been easier for the companies to launch while Qsymia was still only available through mail-order pharmacies. Of course, the companies have a bit more time since VIVUS said it could take up to 90 days before Qsymia would be available in retail pharmacies.

The FDA's lighter stance is good news for Orexigen (NASDAQ: OREX  ) , which is hoping to reapply for approval of its obesity drug Contrave later this year or early 2014. After taking a hard-lined stance, rejecting three obesity drugs over a few months, the agency has continued to signal that it's willing to work with obesity drugmakers, which should smooth Contrave's approval process.

The modified REMS will help boost sales of Qsymia since patients are used to picking up prescriptions at pharmacies rather than ordering through a mail-order pharmacy. The change should also make things simpler for the doctor, which won't have to coordinate with the mail-order pharmacies.

While the change will help, it's not sufficient by itself to get Qsymia sales to blockbuster status. VIVUS still faces an uphill battle to get insurers to pay for the drug. Without coverage, many patients are going to experience sticker shock no matter where they go to get their drug.

What macro trend was Warren Buffett referring to when he said "this is the tapeworm that's eating at American competitiveness"? Find out in our free report: What's Really Eating At America's Competitiveness. You’ll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.

Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2455120, ~/Articles/ArticleHandler.aspx, 9/28/2016 11:26:55 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 1 hour ago Sponsored by:
DOW 18,339.24 110.94 0.61%
S&P 500 2,171.37 11.44 0.53%
NASD 5,318.55 12.84 0.24%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

9/28/2016 4:00 PM
VVUS $1.17 Down -0.03 -2.50%
VIVUS CAPS Rating: **
ARNA $1.77 Down -0.04 -2.21%
Arena Pharmaceutic… CAPS Rating: ***
OREX $3.29 Up +0.05 +1.54%
Orexigen Therapeut… CAPS Rating: **