Industry Briefs

FDA Approves First XR Orally Disintegrating Methylphenidate Tablet

The Food and Drug Administration (FDA) has approvedCotempla XR-ODT, the first extended-release, orally disintegrating methylphenidate tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17.

The approval of Cotempla XR-ODT was based in part on the results of a phase 3 clinical trial of children in a laboratory classroom setting, according to manufacturer Neos Therapeutics Inc. The study found that children who took Cotempla XR-ODT experienced significantly improved ADHD symptoms compared with placebo; effects were evident after one hour and lasted through 12 hours. The adverse-event profile for Cotempla XR-ODT was consistent with the established safety profile of other extended-release methylphenidate products.

Neos expects Cotempla XR-ODT will be available in fall 2017.

NGF Inhibitor Receives FDA Fast-Track Designation for Treatment of Chronic Pain

Pfizer and Eli Lilly recently announced that the FDA has given a fast-track designation to the nerve growth factor (NGF) inhibitor tanezumab for the treatment of chronic pain in patients with osteoarthritis and chronic low back pain.

Tanezumab is an antibody that works by selectively binding to and inhibiting NGF, which is elevated in response to injury, inflammation, and chronic pain. By inhibiting NGF, tanezumab may help prevent pain signals produced in peripheral tissues from reaching the spinal cord and brain. Tanezumab is being tested in a phase 3 clinical program that includes six trials and approximately 7,000 patients with osteoarthritis, chronic low back pain, or cancer pain; results are expected sometime in 2018.

Other companies have been trying to develop NGF inhibitors as analgesics, though this class of drugs has had many setbacks. Last year, the drug candidate fasinumab was placed under a clinical hold by the FDA due to concerns of joint damage. ■