Archive for April, 2008

Nano-technology gel to aid spinal chord injury patients

Researchers at Northwestern University have come up with a nano-engineered gel that has been shown to curb the formation of scar tissue at the site of spinal injuries, thereby allowing the spinal chord fibers to regenerate. The gel has to be injected into the spinal chord as a liquid, which then turns into a scaffold, supporting the new nerve fibers.

Pramipexole might help reduce sleep disturbance

AAN LogoA new study has shown that pramipexole (Mirapexin®/Sifrol®) can significantly reduce sleep disturbance, often the most troublesome symptom experienced by people with Restless Legs Syndrome (RLS). The important finding, presented at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago, U.S.A., highlights the benefit of an RLS treatment, which effectively targets the core symptoms of the condition, such as an uncontrollable urge to move the legs, as well as secondary symptoms, including sleep disturbance.

FDA approves stronger version of Imitrex

Pozen Logo  Pozen Inc. and GlaxoSmithKline Inc. have received the FDA approval for their Treximet drug, a combination of naproxen sodium and sumatriptan, for the treatment of migraine. The drug is a follow-up to GlaxoSmithKline’s blockbuster migraine drug, Imitrex. GSK LogoGlaxoSmithKline said that clinical trials of Treximet indicate that the drug provided migraine relief at two hours for a significantly greater percentage of patients than Imitrex 85 mg or naproxen sodium 500 mg alone.

Rituxan fails to meet primary endpoint in Phase II/III study for PMS

Genentech and Biogen Idec’s Phase II/III study of Rituxan (rituximab) on patients suffering from primary-progressive multiple sclerosis failed to meet its primary endpoint, which was the time to confirmed disease progression during the 96-week treatment period. The randomized, double-blind, placebo-controlled, multi-center study evaluated the efficacy, safety and tolerability of four courses of Rituxan in 439 patients. Most events in the Rituxan arm were mild to moderate and the overall adverse event rates for the drug were 16.4%, as compared to 13.6% for placebo.

Tentative FDA approval for Lamotrigine ANDA

Taro LogoFDA has granted approval to the Abbreviated New Drug Application (ANDA) filed by Taro Pharmaceutical Industries Ltd. for Lamotrigine Tablets. The product is used in the treatment of seizures and the tentative FDA approval means that the tablets meet the substantive requirements for approval, but can be marketed only after the final approval has been granted.