A small Texas pharmaceutical company that is building a sales and marketing headquarters in Blue Bell has won Food and Drug Administration approval for a first-of-a-kind treatment for Attention Deficit Hyperactivity Disorder in patients 6 years and older.

Neos Therapeutics Inc. secured final FDA approval late Wednesday for Adzenys, the first oral tablet for ADHD that dissolves in the mouth in less than 30 seconds, and does not require swallowing a pill or capsule.

Adzenys is an amphetamine and the bioequivalent of Shire PLC's Adderall XR, said the company, whose local operation is headed by a former Shire employee. It will be available in pharmacies in the second quarter, by June 30.

Adzenys XR-ODT will compete with Shire's Adderall and Vyvanse and other ADHD treatments such as Concerta and Ritalin.

ADHD is a common childhood disorder that affects 5 percent of children and 2.5 percent of U.S. adults, according to the National Institute of Mental Health. Symptoms include poor concentration, hyperactivity, and impulsiveness.

Neos Therapeutics, which has 100 employees, put its commercial headquarters in Blue Bell last year after Shire relocated its corporate headquarters from the Chesterbrook Corporate Center near Valley Forge to Lexington, Mass.

Thomas P. McDonnell worked for Shire for a decade in many roles, including vice president of marketing in neurosciences, at Chesterbrook.

"When they decided to move to Boston, I decided not to. It was a great company, and I had a great run. But I had an opportunity to start a commercial headquarters in Philadelphia with Neos Therapeutics."

"I just happened to have access to a lot of talent," McDonnell said.

Neos made an initial public offering (IPO) in July and got FDA approval late Wednesday after the stock market closed, at 6 p.m., for "the first ever extended-release oral disintegrating tablet"for ADHD, he said.

"There are lots of people who either don't like to, or cannot swallow, pills or capsules," McDonnell said. "Especially in ADHD in children, parents have either had to put it in apple sauce or come up with different solutions to try to get the child medication."

The company's market research showed that "a lot of people would prefer" to take medicine that dissolves on the tongue "vs. a pill or capsule."

McDonnell has hired a sales, marketing, commercial operations, medical affairs, and regulatory compliance staff of 12 in Blue Bell, and he hopes to have 15 to 20 employees within a year.

"We are actively looking and hiring," he said. "My motivation is to build a great life-science company in this area. We're using local suppliers as much as we can."

The company's manufacturing, research and development will remain in Dallas.

Neos Therapeutics is working on a second oral-dissolving ADHD medicine, containing methylphenidate, a different chemical compound, not amphetamine-based, that the company hopes to launch in 2017.

"We are trying to provide another option for physicians and patients and give them the flexibility to either use a methylphenidate or an amphetamine with the oral-dissolving technology."

Neos stock closed up $3.96, or 42 percent, to $13.38 Thursday on the Nasdaq exchange.

lloyd@phillynews.com

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