November FDA Pipeline

November 1, 2004

New indications

New indicationsCymbaltaDuloxetine LILLY

SSNRI APPROVED AS FIRST TREATMENT

FOR DIABETIC PERIPHERAL NEUROPATHIC PAIN

New formulationsParcopaCarbidopa-levodopa orally disintegrating tablets SCHWARZ PHARMA

RAPID-DISSOLVING PARKINSON'S TABLET APPROVED FOR EASE OF DOSING

Since current evidence indicates that the symptoms of Parkinson's disease are related to a depletion of dopamine in the corpus striatum, levodopa has been chosen as a therapy because it crosses the blood-brain barrier to the brain, where it is presumably converted to dopamine. Carbidopa inhibits the decarboxylation of peripheral levodopa, which reduces the dose of levodopa necessary to produce a response in Parkinson's disease patients, thereby lessening the severity of levodopa-associated adverse events. The carbidopa-levodopa orally disintegrating tablet is designed to deliver this synergistic combination of agents in a formulation that allows for ease-of-use among patients experiencing "off" periods. The orally disintegrating tablet formulation of carbidopa-levodopa was approved on August 27, 2004, for the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

FDA Actions in brief A scent-free formulation of mometasone nasal spray 50 mcg (Nasonex, Schering-Plough) received FDA approval.

FDA approved extending the shelf-life of the paclitaxel-eluting coronary stent (Taxus Express2, Boston Scientific) from six months to nine months.

New formulations of methylphenidate (Methylin, Alliant Pharmaceuticals) were approved by FDA. The drug is now available in chewable tablets and an oral solution for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged six years or older.

An expanded indication was approved for adalimumab (Humira, Abbott) to include improvement in physical function for adult patients with moderately-to-severely active RA.

Tegaserod (Zelnorm, Novartis) was approved to treat chronic idiopathic constipation in male and female patients aged less than 65 years.

FDA approved an expanded indication for ziprasidone (Geodon, Pfizer) to include the treatment of acute bipolar mania, including manic and mixed episodes.

The pregnancy rating for budesonide (Rhinocort Aqua, AstraZeneca) was upgraded to Category B, indicating studies have sufficiently demonstrated that the nasal spray does not increase the risk of congenital malformations to the fetus during pregnancy. Budesonide is the first and only intranasal corticosteroid to receive this rating for allergic rhinitis.

Desloratadine (Clarinex Syrup, Schering-Plough) was approved for relieving symptoms associated with seasonal allergic rhinitis in pediatric patients aged two years or older. Desloratadine syrup was also approved for relieving symptoms of perennial allergic rhinitis and chronic idiopathic urticaria in children aged 6 months or older.