The US Food and Drug Administration (FDA) has approved a new formulation of methylphenidate for children with attention-deficit/hyperactivity disorder (ADHD). Cotempla XR-ODT (Neos Therapeutics Inc) is the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of ADHD in patients aged 6 to 17 years, the company said [...]
Seven years after safety concerns altered the trajectory of Pfizer’s stop-smoking med Chantix, the FDA has pulled its black-box warning from the drug’s label, according to a well known online pharmaceutical news site, FiercePharma. FDA officials removed the warning after weighing data from the EAGLES postmarketing study showing that Chantix [...]
Promising research into PTSD and the psychological effects of cancer such as anxiety and depression, have cast new light on the party drug, ecstasy (MDMA), and a hallucinogenic ingredient in "Magic Mushrooms" (psilocybin). In a paper posted online, Michael and Ann Mithoefer, the husband-and-wife team offering the treatment — which combines [...]
The New York Times will report tomorrow that an experimental drug derived from marijuana has succeeded in reducing epileptic seizures in its first major clinical trial, the product’s developer announced on Monday, a finding that could lend credence to the medical marijuana movement. The developer, GW Pharmaceuticals, Epidiolex, achieved the [...]
In the summer of 1997, I was months away from launching the first consumer magazine about mental illness. My company had acquired a state and federal trademark for the title, Mental Fitness (The Science of Mental Wellness). I had done a long interview with the veteran 60 Minutes journalist, Mike [...]
In a clear signal that medicine and politics make strange bedfellows, a crucial Senate committee on Tuesday, which unanimously approved Dr. Robert M. Califf, a cardiologist and clinical trial expert from Duke University as the commissioner of the Food and Drug Administration, is unlikely to happen soon, because Senator Lisa Murkowski [...]
SILVER SPRING, Md. — A panel of medical experts recommended Tuesday that the Food and Drug Administration approve a new way of treating opioid addicts, using a slender rod implanted into the arm that delivers medicine for months at a time, according to today's New York Times. Some doctors say [...]
The US Food and Drug Administration (FDA) has approved a chewable tablet form of extended-release methylphenidate (QuilliChew ER, Pfizer Inc) for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, the company announced today. The chewable product will be available in tablet form in strengths of 20, 30, and [...]
The US Food and Drug Administration (FDA) has approved an injectable, long-acting version of Alkermes Inc's atypical antipsychotic aripiprazole to treat adults with schizophrenia. Aripiprazole lauroxil (Aristada) is administered every 4 to 6 weeks as an injection in the arm or buttocks. The company said it expects to launch the [...]
The US Food and Drug Administration (FDA) has approved the amphetamine Dyanavel XR (Tris Pharma Inc), a once-daily extended-release oral liquid, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, the company has announced. According to the company, the approval is based on a phase [...]