FDA approves first drug for Parkinson’s-related hallucinations, delusions
SILVER SPRING, Md. — The Food and Drug Administration recently approved a new drug that treats delusions and hallucinations that are associated with psychosis affecting patients with Parkinson’s disease.
Nuplazid (pimavanserin), from Acadia Pharmaceuticals, is the first medication to be approved to treat Parkinson’s-related psychosis, which affects some 40% of the 4-6 million patients with Parkinson’s disease. The drug was granted breakthrough therapy designation and a priority review by the FDA.
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
Acadia expects Nuplazid to be available in June.
Allergan to offer Liletta IUD at discount to VA
DUBLIN — Allergan on Monday announced the launch of its “Liletta Access on the Front Line” initiative, which is aimed at allowing active duty and retired military members better access to long-acting reversible contraception.
The initiative will see Allergan offering its Liletta IUD to military treatment facilities and Veterans Affairs hospitals at a Federal Supply Schedule price of $55.83. According to VA estimates, the price range for IUD costs to the military is $350 to $650 per device. Additionally, according to a recent article in Contraception, 59% of women in the military don’t discuss contraception with a healthcare provider before being deployed. Once deployed, a third of them can’t obtain their birth control and 41% have difficulty refilling their birth control prescriptions.
“As a leader in women's healthcare, Allergan is taking bold steps to help overcome barriers to patient access to IUDs in order to provide women with affordable, and accessible birth control options,” Allergan’s women’s healthcare VP Aimee Lenar said. “This military initiative provides servicewomen with information and access to make educated and cost-effective birth control decisions.”
FDA approves oral suspension of Eisai’s Fycompa
SILVER SPRING, Md. — The Food and Drug Administration has approved Eisai’s Fycompa (perampanel) oral suspension, the company announced Monday. The oral suspension has been approved to treat partial-onset seizures with or without secondary generalized seizures, as well as for primary generalized tonic-clinic (PGTC) seizures in patients with epilepsy older than 12.
“We are excited about the approval of FYCOMPA Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids,” said Dr. Lynn Kramer, Eisai’s chief clinical officer and chief medical officer of its neurology business group. “The development of this new formulation underscores Eisai's commitment to advancing epilepsy care by making contributions to help address the diversified needs of epilepsy patients and their families.”
The new oral formulation is interchangeable with the company’s Fycompa tablets, and Eisai expects to make it available in June. The drug comes with a boxed warning for serious psychiatric and behavioral reactions.
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