Orexigen® Therapeutics is developing a new fixed dose sustained-release (SR) combination of naltrexone and bupropion for the treatment of obesity. The rationale behind the two active ingredients is stated to be: Bupropion acts on the weight control circuit by stimulating the POMC neuron. Naltrexone prevents inhibition of POMC neurons by blocking the action of β-endorphin [...]
Archive for June, 2010
India Tightening Inspections on Raw Materials
Published June 25th, 2010 in Uncategorized. 0 CommentsCheaper is not always better. The cost of drug development demands that the pharmaceutical industry review the cost of all components of the program. In doing this, often the choice of the active pharmaceutical ingredient (API) manufacturer is driven by cost. Many of the API’s and raw materials are now coming from China. Any company [...]
Labeling for Abuse-Deterrent Drugs
Published June 10th, 2010 in Formulation Issues and News Commentary. 0 CommentsThis past Tuesday (6/8/2010), we participated in a DIA-sponsored webinar entitled Understanding the Development and Label Allowances for 505(b)(2) Abuse-Deterrent Products. Joining me, Ruth Stevens our CSO and Cindy Phurrough, our Clinical Operations head, was Dr. Lynn Webster, Chief Medical Officer of Lifetree Clinical Research and Pain Clinic. Ruth reviewed the regulatory background, the types [...]