Industry Briefs

FDA Approves Extended-Release Orally Disintegrating Tablet for ADHD

Last week Neos Therapeutics announced that the Food and Drug Administration (FDA) approved Adzenys XR-ODT for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. The recent approval makes the amphetamine the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.

According to a statement by the company, “Adzenys XR-ODT was approved by the FDA via the 505(b)(2) regulatory pathway. The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR).” Adzenys XR-ODT will be available in six dosage strengths, equivalent to Adderall dosage strengths.

The most common adverse reactions reported by patients of all ages who took Adzenys XR-ODT included loss of appetite, insomnia, and abdominal pain. Additional side effects in adults who took Adzenys XR-ODT included tachycardia, urinary tract infections, and agitation.

Patients should not take Adzenys XR-ODT if they are hypersensitive to amphetamine or are taking or have taken monoamine oxidase inhibitors within the past 14 days.

FDA to Consider Brintellix for Treatment of Cognitive Dysfunction in MDD

On Wednesday Takeda Pharmaceutical Company Limited and H. Lundbeck A/S announced that the FDA Psychopharmacologic Drugs Advisory Committee voted 8-2 to expand the indication for the antidepressant Brintellix (vortioxetine) to include cognitive dysfunction in adults with major depressive disorder (MDD).

The committee’s decision was based on data presented by the two companies from two, eight-week, randomized trials with approximately 1,000 people with MDD that showed Brintellix (at 10 mg/day and 20 mg/day) demonstrated a statistically significant improvement in cognitive performance over placebo and the antidepressant duloxetine.

The advisory committee’s recommendation for Brintellix will be considered by the FDA during its review of the Brintellix Supplemental New Drug Application. The agency is expected to make a final decision by March 28. ■