PHARMACY

St. Charles Pharmaceuticals receives grant for research on new analgesic

BY Diana Alickaj

NEW ORLEANS St. Charles Pharmaceutical has announced that it has received funding for the first year of three for a research grant from the National Institute of Neurological Disorders and Stroke.

St. Charles Pharma is a Louisiana based company that will use the award, technically a Cooperative Small Business Phase II SBIR Grant for Translational Research, to fund the research of SCP-123, which the company is working hard to place into clinics. The award will also work in funding the preparation of the application to be submitted to the FDA.

SCP-123 is an analgesic that treats neuropathic pain, and according to published reports, offers greater pain reduction, reduced side effects and has the potential to also treat acute, migraine, post-operative and pediatric pain.

“We are excited. Dr. Narducy and his research team have now raised $6 million in NIH grant funding to support the Company’s drug development efforts,” John Koerner, St Charles’ chairman, stated. “If all goes well, SCP-123 could fill a large, unmet medical need and become a drug of first choice—a blockbuster—for the treatment of neuropathic pain. This grant award is a big plus toward mitigating development risk and making it all happen.”

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Possible new FDA diabetes drug guidelines could delay approvals

BY Drew Buono

SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.

The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.

That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.

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FDA approves Ranbaxy’s generic version of Risperdal

BY Drew Buono

NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.

Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.

Risperdal had sales of $924 million in 2007.

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