Content about Neurological disorders

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

JERUSALEM — Multiple sclerosis patients treated with a drug made by Teva Pharmaceutical Industries showed a "significant" reduction in their loss of brain volume, according to a new study.

Results of a five-year study published in the Journal of the Neurological Sciences found that Copaxone (glatiramer acetate) produced significant reductions in patients' loss of brain volume compared with other disease-modifying therapies.

CHARLOTTE, N.C. — Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

The drug maker announced the submission of a new drug application for Northera (droxidopa) as a treatment for neurogenic orthostatic hypotension. NOH predominantly affects people with primary autonomic failure, a group of diseases that includes Parkinson's, multiple system atrophy and pure autonomic failure.

SCHAUMBURG, Ill. — Generic drug maker Sagent Pharmaceuticals has launched a new drug for neuromuscular disorders, the company said.

Sagent announced the launch of vecuronium bromide, an injectable drug used to treat myasthenia gravis and Eaton-Lambert syndrome. The disorders cause muscle weakness and fatigue.

The market for vecuronium bromide is about $10 million in the United States, according to IMS Health.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

Novartis Pharmaceuticals announced the FDA's approval of Gilenya (fingolimod) for the reduction of T1 gadolinium-enhancing lesions, areas of inflammation in the central nervous system that mark disease activity in people with MS.

SCHOFIELD, Wis. — PuraMed BioScience on Monday announced that headache researcher Roger Cady will be exhibiting a poster presentation of his independent clinical study of PuraMed's nonprescription migraine medication LipiGesic-M at the 2011 Headache Update Conference being held in Orlando, Fla., July 14 to 17.

JERUSALEM — An investigational drug made by Teva Pharmaceutical Industries and Active Biotech for multiple sclerosis reduced disease relapses and prevented the progression of disability, according to late-stage clinical trial results announced Monday.

GREENSBORO, N.C. — Merz Pharmaceuticals has created two programs to provide financial assistance to patients using its drug for cervical dystonia, the company said Tuesday.

The programs — the Xeomin patient co-payment program and the Xeomin patient assistance program — cover Xeomin (incobotulinumtoxinA), designed to decrease the severity of abnormal head positions and neck pains in patients with the disease, which causes muscle contractions resulting in repetitive movements and abnormal postures.

DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

LOUISVILLE, Ky. — US WorldMeds has announced a new treatment for migraines, the drug maker said Wednesday.

The company announced the launch of Alsuma auto-injector (sumatriptan), which injects the drug sumatriptan under the skin via a single-use, prefilled auto injector. The company is selling the drug under a licensing agreement from King Pharmaceuticals.

IRVINGTON, N.Y. — Prestige Brands Holdings on Thursday announced that it has entered into a definitive agreement to acquire the assets associated with the Dramamine business in the United States from McNeil Consumer Healthcare for $76 million in cash.

“The company expects to quickly and smoothly integrate Dramamine into the Prestige portfolio and drive growth through enhanced brand support,” stated Matthew Mannelly, Prestige Brands CEO.

INDIANAPOLIS The Food and Drug Administration has approved a new usage for a drug used to treat depression and pain.

Eli Lilly said Thursday that the FDA had approved Cymbalta (duloxetine hydrochloride) for treating chronic musculoskeletal pain. This is the fifth indication for which the agency has approved Cymbalta, after major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, Lilly said.