Latebreakers: February 20, 2006

Women to sue Wal-Mart over EC

Three Massachusetts women plan to go to court to force Wal-Mart to stock emergency contraceptive (EC) agents in all its pharmacies in the state. The plaintiffs contend that state pharmacy regulations require pharmacies to stock commonly prescribed medications. Wal-Mart has repeatedly asserted that it does not carry EC for business reasons and that company policy is to refer a customer to a competitor who does stock the product. However, the giant retailer does stock EC in its Illinois pharmacies to comply with state law.

Walgreens R.Ph.s sue over dispensing EC

Targeted anticancer drug OK'd

Pfizer has received FDA approval for its tyrosine kinase inhibitor, sunitinib malate (Sutent), an oral, multitargeted cancer therapy. The drug underwent a six-month priority review and is indicated as a treatment for gastrointestinal stromal tumors after disease progression or intolerance to imatinib mesylate (Gleevec, Novartis) and for the treatment of advanced renal cell carcinoma. Sunitinib inhibits multiple receptor tyrosine kinases necessary for tumor growth, angiogenesis, and the metastatic progression of cancer. Pfizer Oncology's FirstRESOURCE support program is available to Sutent patients and prescribers at 1-(877) 744-5675; it offers patient assistance and reimbursement information. According to the manufacturer, the drug will be available this month.

New drug approved for chronic constipation

The FDA has approved lubiprostone (Amitiza, Takeda/Sucampo Pharmaceuticals) for the treatment of idiopathic chronic constipation. The drug is the first and only chloride-channel blocker and works by increasing fluid secretion into the intestinal tract by locally activating specific ClC-2 chloride channels on cells lining the small intestine. The most common side effects seen in clinical trials included headache, nausea, diarrhea, abdominal pain, and distension. Lubiprostone should be taken twice a day with food, and patients should be periodically assessed to determine the need for continued treatment. Chronic idiopathic constipation is the infrequent and difficult passage of stool and is more common in women and people over the age of 65.

First inhaled insulin gets FDA nod

Pfizer has announced FDA approval for Exubera (insulin human [rDNA] origin) Inhalation Powder, marking the first time a non-injectable form of insulin has been available for use in the United States. The inhaled insulin is indicated for the treatment of adults with Type 1 and Type 2 diabetes and was found to be as effective as short-acting insulin injections in clinical trials. Exubera is not recommended for use by smokers or recent smokers or people with chronic lung disease, such as asthma. Baseline lung function tests are recommended before initiation of treatment and should be repeated every six to 12 months thereafter. Each filled prescription should be accompanied by an FDA-approved Medication Guide with information on proper use of the inhaler. According to the company, Exubera will be available in pharmacies by mid-2006.