Latebreakers: June 5, 2006

New MAOI for Parkinson's approved

Teva has received permission from the FDA to market rasagiline (Azilect) for the treatment of Parkinson's disease (PD). The new molecular entity is a monoamine oxidase type B inhibitor that works by blocking the breakdown of dopamine. Rasagiline was approved as an initial single-drug treatment in early PD and in addition to levodopa in more advanced patients. Like other MAOIs, rasagiline has the potential to cause a hypertensive crisis if a patient consumes tyramine-containing foods while on therapy. The efficacy of the new drug was tested in 404 patients with early disease and 1,100 patients with more advanced PD.

NCPA debunks PBM 30-day pay pledge

Another chance for smokers with Chantix

Smoking-cessation drug varenicline tartrate (Chantix) from Pfizer has been given the FDA nod following a priority review. Varenicline therapy includes a 12-week course of treatment, with an additional 12 weeks recommended for those patients who were able to quit, increasing the chances of long-term smoking cessation. The drug's superior efficacy compared with placebo was demonstrated in five of six clinical trials involving more than 3,600 patients. In two of the five trials, patients treated with varenicline were more successful in giving up smoking than patients treated with bupropion (Zyban, GlaxoSmithKline). According to Pfizer, varenicline works by partially activating the nicotinic receptors in the brain and reducing the severity of cravings and withdrawal symptoms from nicotine.

Medicare Rx discount cards end

CMS issued a guidance reminding pharmacists that the Medicare-approved Drug Discount Card program ended on May 15. Pharmacists should advise any patients trying to use their discount cards to contact the customer service department of their card sponsor or phone 1-(800) MEDICARE. The agency has asked discount card sponsors to work with pharmacies to resolve claims reversals and late claim filings by Aug. 15. CMS noted that the guidance does not apply to drug manufacturer or state patient assistance programs.

Accreditation now open to compounding pharmacies

The Pharmacy Compounding Accreditation Board (PCAB) is now accepting applications from compounding pharmacies that wish to apply for accreditation. To earn the PCAB seal of approval, compounding pharmacies must meet strict quality and safety standards, according to executive director Ken Baker. For more information, go to http://www.pcab.info/.

FDA wants new labels for LABAs

The FDA has requested that manufacturers of long-acting beta-2 adrenergic agonists (LABAs) update their labeling with new warnings and provide medication guides for patients alerting them to the possibility of severe asthma episodes and death while using the products. Studies have shown that an increased number of patients using LABAs with other asthma medications died compared with those taking placebo and other asthma meds. In the FDA's public health advisory, the agency said that even though LABAs decrease the frequency of asthma attacks, the attacks tend to be more severe when they do occur. The inhalers affected include salmeterol xinafoate inhalation powder (Serevent Diskus, GlaxoSmithKline), fluticasone propionate and salmeterol inhalation powder (Advair Diskus, GlaxoSmithKline), and formoterol fumarate inhalation powder (Foradil Aerolizer, Novartis).