FDA Approves Grand Prairie Pharma Company’s ADHD Drug, Stock Jumps

Grand Prairie pharmaceutical company Neos Therapeutics Inc. this week got the go-ahead from the FDA to produce a drug similar to Adderall XL, which is prescribed to patients with attention deficit/hyperactivity disorder.

The approval caused its stock to shoot up by more than 42 percent, hitting $13.29 after a 52 week low of $8.91, according to Business Finance News. The drug, called Adzenys XR-ODT, is bioequivalent to the popular Adderall XL. The company says it is the first extended-release orally disintegrating tablet for the treatment of ADHD, and will be safe to prescribe in patients six and older. Most of the drugs approved to treat ADHD are tablets or capsules—the patient must swallow a pill or sprinkle it on food. This dissolves on the tongue, and is coated with a sweet flavoring to mask any chemical taste.

Neos Therapeutics will sell the drug in six different strengths, just as Adderall XL is sold. Dr. Vipin Garg, the company’s president and CEO, says in a release that staffers will begin speaking with physicians immediately although the drug will not be available until the second quarter of this year. The drug’s makeup is patent-protected and is not generic extended release amphetamine salts.

The National Institutes of Health estimates that 5 percent of children and 2.5 percent of adults suffer from ADHD.

Posted in News, Pharmaceuticals.