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Neos Therapeutics’ Controlled-Release ADHD Drug Get FDA Approval

Xconomy Texas — 

Dallas—The FDA late Monday approved Neos Therapeutics’ controlled-release version of an old ADHD therapy, methylphenidate.

Neos (NASDAQ: NEOS) says its formulation of methylphenidate (Cotempla XR-ODT) is the first methylphenidate tablet designed to deliver the medication in a gradual manner over time—instead of all at once—and is able to orally disintegrate on the tongue to treat attention-deficit/hyperactivity disorder in patients from 6- to 17-years-old.

“With this approval, Neos will be the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form,” said Vipin Garg, Neos’ president and CEO, in a press release.

Methylphenidate, sold under the name Ritalin and among other names, and amphetamines such as Adderall, form the current standard of care for ADHD. But many children have difficulty swallowing these large pills. Neos essentially has reformulated those drugs to be available in a tablet that the company says is easier for children to take and releases the medicine over an extended period of time.

Cotempla XR-ODT will be commercially available in a portable, child-resistant blister pack in the fall of 2017, according to the press release. It will join Neos’ other ADHD drug, Adzenys XR-ODT, the company’s version of dextroamphetamine (Adderall XR), which was commercially launched in May 2016.

Neos resubmitted its application for FDA approval for Cotempla XR-ODT in December following a ruling from the regulator requiring a new study to better establish that the version of the drug tested in clinical trials and the one the company wanted to sell were the same.

After raising nearly $40 million in equity investment to develop its drug products, Neos went public in 2015 and raised $72 million, pricing 4.8 million shares at $15 a share. On Monday, Neos stock was up 35 cents, or 4 percent, to close at $9.