Osteoarthritis Drug Okayed

By William T. Elliott, MD, FACP

Boehringer ingelheim has received approval to market a new NSAID. Meloxicam (Mobic) was approved for the treatment of osteoarthritis. The once-a-day drug is not a selective COX-2 inhibitor, but shows preferential inhibition of COX-2 over COX-1, and seems to have a low incidence of gastrointestinal side effects.

Residronate (Actonel) has been approved for the treatment of osteoporosis. The drug, marketed by Procter & Gamble and Aventis Pharmaceuticals, was approved for the treatment of postmenopausal osteoporosis as well as glucocorticoid-induced osteoporosis, the first drug ever to receive this second indication. Similar to etidronate, physicians need to be aware of the risk of esophageal or gastric ulcers in patients taking the drug.

Linezoid, a new broad spectrum antibiotic with activity against resistant bacteria, was approved in April. The drug will be marketed under the trade name Zyvox by Pharmacia Corp. The drug, which is available in both a parenteral and oral form, was approved for treatment of pneumonia and cutaneous infections. Linezoid is especially promising because it is effective against methicillin- and vancomycin-resistant gram-positive organisms including methicillin-resistant staph and vancomycin-resistant enterococcus (VRE). The drug is the first of a new class of antibiotics known as oxazolidiones.

A new ultra-long-acting insulin preparation has been approved for use in diabetes type 1 and 2. Advantis’ insulin glargine injection (Lantus) is approved for once daily administration at bedtime in adults with type 2 diabetes and for adults and children with type 1 diabetes. The drug is a recombinant human insulin analog that has a flat concentration time profile over 24 hours. NPH insulin, in contrast, exerts its effect over 14 hours.

Novartis Pharmaceuticals has received FDA approval for its new Alzheimer’s drug rivastigmine tartrate. The drug, approved for treatment of mild to moderate Alzheimer’s disease, will be marketed under the trade name Exelon. Rivastigmine is a cholinesterase inhibitor similar to the other two Alzheimer’s drugs currently on the market, tacrine (Cognex) and donepezil (Aricept). Novartis is touting the drug as having a low incidence of liver toxicity. It will be available in four dosage forms to aid in titration.

Bristol-Myers Squibb has withdrawn its FDA application for omapatrilat (Vanlev), a unique new antihypertensive drug. The company had high hopes for the drug, which was the furthest along in a new class of antihypertensives known as vasopeptidase inhibitors. These drugs, which are potent antihypertensives, block the angiotensin converting enzyme and another enzyme—neutral endopeptidase. Omapatrilat was withdrawn because of the FDA’s concern about its safety, specifically a tendency to cause angioedema. Clinical studies of the drug in heart failure and hypertension are continuing, and it is likely that the company will bring the drug back to the FDA before the end of the year. Several other pharmaceutical companies are also working on vasopeptidase inhibitors.

The FDA has granted Novartis Pharmaceuticals a priority review for its new drug for the treatment of irritable bowel syndrome, tegaserod (Zelmac). The drug targets and modulates serotonin 5HT4 receptors which are present throughout the gut, and are felt to be responsible for motility and pain perception. The FDA recently approved alosetron (Lotonex), a 5HT3 receptor antagonist for the same indication.

New Indications

Two over-the-counter preparations of ibuprofen have been approved by the FDA for the treatment of migraine. Motrin Migraine was the first approved, and is now joined by Advil Migraine, which is formulated in a liquid-filled capsule. These two products join Excedrin Migraine in this highly competitive market. Unlike Excedrin Migraine, neither ibuprofen product contains caffeine.

Divalproex (Depakote) may improve behavior in children and adolescents with certain severe disruptive behavior disorders that are marked by explosive temper caused by irritable mood swings. The drug was evaluated in a small, double-blind, placebo-controlled crossover study of 20 outpatients age 10 to 18. Eighty percent of those receiving the drug responded with improved behavior (Am J Psychiatry 200;157:818-820).

Clinical

TAP Pharmaceuticals’ new erectile dysfunction drug apomorphine (Uprima) is nearing approval despite concerns that the drug may cause hypotension and syncope. The drug was recommended for approval by the FDA’s Urology Subcommittee on April 10, clearing the way for full approval in the next few months. Apomorphine is a sublingual preparation that acts centrally, as opposed to sildenafil (Viagra), which acts on pelvic vasculature.

The US Headache Consortium has published new clinical guidelines for the diagnosis and treatment of migraine. The new guidelines note that only 5% of migraine patients receive prophylactic therapy, and therefore recommend preventative treatment for patients who have two or more headaches per month. Recommended prophylactic treatments include divalproex, propranolol, and timolol (Neurology 2000;54:1553).