Neos wins FDA approval for a melts-in-your-mouth take on Adderall for ADHD

Neos CEO Vipin Garg

Neos Therapeutics ($NEOS), at work on extended-release versions of old drugs, won FDA approval for a long-acting ADHD pill that dissolves in patients' mouths.

The drug, Adzenys XR-ODT, is an amphetamine-based tablet akin to Shire's ($SHPG) Adderall, packaged in Neos' proprietary polymers that allow it to disintegrate without needing to be swallowed. The pill is cleared for once-a-day administration in ADHD patients 6 and older, Neos said, and the company plans to launch it in 6 dosage strengths next quarter.

The approval sent Neos' stock price up as much as 67% on Thursday morning before it settled down to around $12.50 a share, 30% above the company's Wednesday close.

"This first ever FDA approval of a product using our proprietary extended-release, orally disintegrating tablet technology is an important milestone for Neos," CEO Vipin Garg said in a statement. "We believe that Adzenys XR-ODT will provide an important innovation for treatment in the ADHD market, and we intend to begin educating healthcare providers about our exciting new product immediately."

Competing with established generics in ADHD will be an uphill battle for Neos, but the company believes it can pick up market share thanks to Adzenys XR-ODT's relative ease of administration, especially for children.

The Dallas company is working to move on from a November FDA rejection of Cotempla XR-ODT, an orally disintegrating version of Ritalin. The agency asked Neos to conduct a new study to better establish the bioequivalence of the version of the drug tested in clinical trials and the one the company hopes to market. Neos hasn't disclosed a timeline for complying with the request.

Neos pulled off a $72 million IPO in July based on the promise of its approach to oral therapies, but the Contempla setback has marred its share value ever since. Despite Thursday's gains, Neos is trading about 17% below its IPO price and more than 50% off of its August all-time high.

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