Breaking News

CMS proposes marketing guidelines for Medicare Part D CMS has developed draft guidelines on what pharmacists can and cannot do with regard to marketing Medicare Part D prescription drug plans in their pharmacies. Following a brief comment period, the proposed Phase II guidelines will be combined with Phase I into a final marketing document. The guidelines and a cover letter are posted on the Web at http://www.cms.hhs.gov/pdps/PrtDPlnMrktngGdlns.asp.

Omnicare and NeighborCare talking Omnicare and NeighborCare Inc. announced that they are in negotiations regarding the proposed acquisition by Omnicare of all the outstanding shares of NeighborCare common stock for $34.75 per share in cash. NeighborCare had rejected an earlier offer from Omnicare. Both companies are leading providers in long-term care pharmacy.

Panel calls for more research on treating chronic insomnia An independent scientific panel convened by NIH reported that many of the medications used to treat chronic insomnia have not yet been rigorously evaluated for long-term use. Panel members also found that despite the side effects and lack of benefit beyond a two-week period, trazodone hydrochloride, a sedating antidepressant, is the most prescribed insomnia treatment. Newer sleep aids, such as zaleplon (Sonata, King Pharmaceuticals), eszopiclone (Lunesta, Sepracor), and zolpidem tartrate (Ambien, Sanofi-Aventis), were noted to be better tolerated than older sleep drugs, such as the benzodiazepines. Full text of the panel's statement is available at http://consensus.nih.gov/.

CMS issues interim final rule on Medicare Part B Specialty pharmacies interested in bidding for the Medicare Part B competitive acquisition program (CAP) should submit their proposal to CMS by Aug. 5. Under this program, doctors can choose to buy their physician-administered drugs from vendors chosen by Medicare through competitive contracting, rather than procuring the drugs themselves, thus affording them more time to devote to clinical work. So stated CMS in the July 6 Federal Register. It is expected that some of the national and regional specialty pharmacy companies will participate in CAP, which, like Medicare Part D, will begin in January 2006.

Topamax approved as stand-alone therapy The FDA has approved the use of Ortho-McNeil's antiepilepsy drug, Topamax (topiramate) Tablets and Sprinkle Capsules, as initial monotherapy in patients 10 years and older with partial-onset or primary generalized tonic-clonic seizures. To-piramate was originally approved for use in combination with other antiepileptic medications to treat partial-onset or primary generalized tonic-clonic seizures, as well as Lennox-Gastaut syndrome. The recommended dose for monotherapy in patients 10 years of age and older is 400 mg per day in two divided doses.

Keppra gains pediatric indication UCB Pharma's antiepilepsy agent, Keppra (levetiracetam), has received FDA approval to be used as add-on therapy in the treatment of partial-onset seizures in children four years of age and older with epilepsy. The approval was based on a randomized study involving 198 children, aged four to 16 years, with partial-onset seizures with or without secondary generalization uncontrolled by standard antiepileptic drugs (AEDs). The children were taking one or two other AEDs at entry. Children treated with levetiracetam had a significant 26.8% reduction in weekly seizure frequency compared with placebo-treated patients. In addition, 44.6% of patients treated with levetiracetam achieved a seizure reduction of at least 50%, compared with 19.6% for placebo. The drug was approved for the same indication in adults in 1999.