Bionovo, Berkeley researcher receive NIH grant to develop obesity drugs
EMERYVILLE, Calif. The National Center for Complementary and Alternative Medicine’s small-business technology transfer program, part of the National Institutes of Health, has given a researcher and a drug maker a grant to develop drugs for obesity and metabolic syndrome in women.
Drug maker Bionovo announced Thursday it received the grant, which it will share with University of California at Berkeley researcher Dale Leitman. The grant will fund the first phase of a study to evaluate Bionovo’s drug based on plant tissue as a prevention for female-specific obesity and metabolic syndrome, which can lead to cardiovascular disease and Type 2 diabetes.
Menopause in women often results in weight gain of 10 lbs. to 15 lbs. and redistribution of fat to the abdomen, which can lead to inflammation and metabolic syndrome.
“Gender differences in health and disease are widely known, yet they have not been sufficiently explored by the biopharmaceutical industry,” Bionovo chairman and CEO Isaac Cohen said. “The potential market for drugs for the treatment of female obesity is enormous.”
FDA to discuss concerns over medicines with DXM
SILVER SPRING, Md. The Food and Drug Administration last week issued an information packet in preparation for a Sept. 14 advisory committee meeting that will address the potential abuse of dextromethorphan products and whether restrictions should be placed on the sale of those over-the-counter cough medicines.
Members of both the FDA Drug Safety and Risk Management Advisory Committee and the FDA Nonprescription Drugs Advisory Committee will be in attendance at the public meeting.
Included in the 135-page packet is a Drug Enforcement Agency summary of that agency’s concerns over the abuse potential of DXM, a list of substances included as part of the Controlled Substances Act, the approval history and OTC monograph of DXM, abuse-related pharmacology reports, a clinical perspective in the treatment of cough, drug utilization data, Drug Abuse Warning Network data, adverse event reports and a review of the Consumer Healthcare Products Association’s website designed to raise awareness among parents and school authorities around the abuse of nonprescription medicines. According to the docket, the CHPA actively has engaged parents and other groups around effective methods in preventing abuse of OTCs and other medicines since May 2006.
“CHPA does not believe scheduling of dextromethorphan under the Controlled Substances Act is warranted,” the association stated in a 93-page briefing book available to meeting attendees. “The prevalence and scope of reported abuse is limited. CHPA believes that there are more effective interventions to address OTC cough medicine abuse in general, and dextromethorphan abuse in particular, that preserve the significant public health benefit of consumer OTC access to these important cough medicines.”
The abuse of DXM products has been the focus of two previous FDA advisory committees. In August 1990, an advisory committee was convened as a result of reports of abuse of DXM containing cough syrups by teenagers in areas of Pennsylvania and Utah. The committee was asked to help the FDA develop a strategy for assessing the problem and discuss possible solutions. The committee recommended that the sponsor provide additional data on the toxicity of the substance in the higher dose range, and that additional epidemiological data be gathered so that the FDA could better assess the scope and significance of abuse, and the risk to the public health.
In July 1992, the committee reconvened and discussed several proposed epidemiological studies on DXM abuse, including conducting a national survey from interviews with drug-free school coordinators, and evaluating attitudes and behaviors of potential and actual DXM abusers and how they might be affected by an abuse prevention program.
“Although no clear consensus on the extent of the problem or solutions came out of this meeting, there was a general recognition, in this early pre-Internet era, that outbreaks of abuse occurred in small communities, that the DXM abuse problem had not risen yet to the national level and further studies should focus on areas where abuse outbreaks are occurring,” the report, issued by Michael Klein, director of the FDA’s controlled substance staff, read.
NCPA launches PharmacyMatching.com
ALEXANDRIA, Va. In an effort to connect independent pharmacy owners looking to sell their pharmacies and those who seek to purchase them, the National Community Pharmacists Association launched a new website that unites the two.
PharmacyMatching.com helps pharmacists navigate every step of the entrepreneurial process from buying to selling a pharmacy, as part of the association’s focus on increasing the number of independent community pharmacy owners throughout the country, NCPA said.
“Now more than ever, the future of community pharmacy depends on the successful transition of ownership to independent owners,” said NCPA president and pharmacy owner Joseph Harmison. “NCPA wants to be independent pharmacy’s source for matching buyers and sellers to keep independents independent.”