Industry Briefs

Naloxone Nasal Spray Gets Approval by FDA

The National Institute on Drug Abuse announced Wednesday that the Food and Drug Administration (FDA) has approved intranasal naloxone—a nasal spray formulation of the medication designed to rapidly reverse opioid overdose.

The new technology has an easy-to-use, needle-free design, providing family members, caregivers, and first responders with an alternative to injectable naloxone for use during a suspected opioid overdose.

The product is developed by Lightlake Therapeutics Inc. and will be marketed by Adapt Pharma Limited under the brand name Narcan Nasal Spray.

FDA Gives Nod to Lupin for Generic Alzheimer’s Drug

This month, Pharma Major Lupin Limited announced that the FDA has approved its generic version of donepezil hydrochloride (marketed as Aricept by Eisai Inc.) for the treatment of dementia of the Alzheimer’s type.

The drug, which will be marketed as a 23 mg tablet, met the necessary bioequivalence standards established by the FDA. Lupin’s U.S. subsidiary, Lupin Pharmaceuticals Inc., will soon begin marketing the product in the United States, according to a press release.

Neuronetics to Launch First TMS Therapy Trials in Adolescents

Neuronetics Inc., developers of Neurostar Transcranial Magnetic Stimulation (TMS) Therapy, has started enrolling adolescents for the first randomized, controlled clinical trial evaluating the acute and long-term effectiveness of TMS therapy in adolescent patients aged 12 to 21 with major depressive disorder (MDD).

The trial will evaluate the safety and efficacy of NeuroStar TMS therapy in approximately 100 adolescent patients in study sites across the United States and Canada. Participants will receive TMS repeatedly over six weeks with follow-up after six months.

NeuroStar TMS therapy delivers magnetic field pulses to the brain, which activates brain structures known to be involved in mood regulation. The system was approved by the FDA in 2008 for MDD in adults. ■