Neos Therapeutics Says ADHD Drug Cotempla XR-ODT Gets FDA Approval

(RTTNews) - Neos Therapeutics, Inc. (NEOS), a pharmaceutical company focused on extended-release or XR products, announced Tuesday that the U.S. Food and Drug Administration approved Cotempla XR-ODT.

It is the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder or ADHD in patients 6 to 17 years old.

The company noted that Cotempla XR-ODT will be commercially available in a portable, child-resistant blister pack in the fall of 2017.

The approval of Cotempla XR-ODT was supported by a Phase 3 clinical trial in children in a laboratory classroom setting. Treatment with Cotempla XR-ODT showed a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day. Onset of effect was evident at one hour postdose and lasted through 12 hours. No serious adverse events were reported during the trial.

Cotempla XR-ODT and Adzenys XR-ODT are Schedule II controlled substances.

Vipin Garg, President and CEO of Neos Therapeutics, said, "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. We look forward to having Cotempla XR-ODT join our Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets on the market this fall."

On Nasdaq, Neos shares gained 4.05 percent in the regular trading and settled at $9. In the after hours, the shares meanwhile declined 7.8 percent to $8.30.