XenoPort Inc. and GlaxoSmithKline PLC have said that the FDA needs three more months to review an application to a neuropathic pain drug being developed by them. The FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010 said the companies. The FDA wanted the companies to develop a strategy to evaluate the drug’s risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.

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An FDA panel voted 12 to 1 that Acoherapeutics Inc’s Phase III trials provided substantial evidence that fampridine sustained-release was effective in improving the walking ability in patients with multiple sclerosis. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee also voted 10 to 2, that there are conditions under which fampridine SR could be safely used as a therapy to improve walking in patients with MS.

The new lab testing of the drug vorinostat indicated that the medication is able to cross the blood-brain barrier and reduce the occurrence of metastatic tumors in mice. The study, published in the September 29 online issue of Clinical Cancer Research, demonstrated that vorinostat reduced the development of large metastatic tumors in mice by 62% as compared a group of mice that did not receive the drug. Although vorinostat has been approved by the FDA for the treatment of cutaneous T-cell lymphoma, it has only been used experimentally as a treatment for other cancers.

Neuralstem Inc has received approval from the US health regulators to start an early-stage human trial of its spinal cord stem cells in Lou Gehrig’s disease, a fatal neuromuscular condition. The trial, which will test the safety of the cells and the surgery procedure, will ultimately consist of 18 patients suffering from the disease, also known as amyotrophic lateral sclerosis (ALS), the company said.

Cylene Pharmaceuticals has announced the initiation of a Phase II clinical trial of quarfloxin (CX-3543) in patients with carcinoid/neuroendocrine tumors (C/NET), which are malignant cancers arising from neural crest cells. Quarfloxin (CX-3543) is a small molecule that disrupts a protein:rDNA complex that forms in the abnormal nucleoli of cancer cells, thereby selectively inducing apoptotic cell death in cancers. In this open-label Phase II trial, quarfloxin will be administered to patients with low or intermediate grade C/NET, including those receiving concomitant treatment with a stable dose of octreotide.

Genentech, Inc. has submitted an application to the U.S. Food and Drug Administration  for its product Avastin® as a therapy for patients of glioblastoma who have received a treatment previously. If the supplemental Biologics License Application (sBLA) is accepted by the FDA, the drug can be considered for a provisional approval for treatment of cancer and other such deadly diseases. Glioblastoma is the most aggressive form of brain cancer. It has no cure. The study found that Avastin, when as evaluated as a single agent, showed that 43 percent of patients experienced no progression of disease.

Novartis Pharmaceuticals Corporation has launched two new dosage strengths of its product Stalevo®, which is approved for use in treatment of Parkinson’s disease. With the approval of 75 and 125 tablets of Stalevo, physicians have another option to prescribe to patients who go through end-of-dose “wearing off”. The product simplifies treatment because it provides more sustained levodopa levels in the blood by combining it with the enzyme inhibitors carbidopa and entacapone.

A recent study has concluded that the use of statin drugs leads to reduction in the risk of Alzheimer’s disease (AD) by 67%. The multi-center trial assessed cognitive changes in the patients for four years. Widely used as drugs to lower cholesterol levels, statins are also safer drugs. Nymox Pharmaceutical Corporation holds global patent rights for the use of statins for the treatment of AD.

he U.S. Food and Drug Administration has provided the patients of schizophrenia with an administration option for RISPERDAL(R) CONSTA(R) ([risperidone] Long-Acting Injection) by approving a new injection site, the deltoid muscle in the arm. RISPERDAL CONSTA was previously approved as a gluteal injection only. The indication was given on the basis of a study which showed that the gluteal and deltoid injections of RISPERDAL CONSTA were bioequivalent routes of administration. The new site is also safe and tolerable. The new packs of RISPERDAL CONSTA will now have two separate with the needle for deltoid injection being smaller gauge and shorter than the gluteal needle in length. RISPERDAL CONSTA is marketed in the U.S. by Janssen(R).

The U.S. Food and Drug Administration has approved AstraZeneca’s once-daily Extended-Release Tablets, SEROQUEL XR (quetiapine fumarate) for the acute treatment of episodes of depression and mania related to bipolar disorder. In the long term, patients suffering from this disease may experience depressive symptoms as long as three times to that of manic symptoms. It must be noted that this is the first such medication approved buy the regulatory authority for treating the serious psychiatric illness.