HEALTH

FDA to discuss concerns over medicines with DXM

BY Michael Johnsen

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.

 

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PacificHealth names Duffner CEO

BY Michael Johnsen

MATAWAN, N.J. PacificHealth Labs on Tuesday announced that Fred Duffner has been promoted to CEO and president reporting directly to the board. Duffner previously had been named president in January 2010.

“We have made great progress this year refocusing the company on its core brands in sports nutrition, reducing expenses and in building our cash position,” Duffner stated. “I believe [PacificHealth] is now in a position to take back its leadership position in the category and begin to lead with new innovation and consumer messaging.”

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Study: SAMe may benefit patients taking antidepressants

BY Michael Johnsen

BOSTON A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital suggested that the dietary supplement S-adenosylmethionine (SAMe) can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication, Pharmavite announced Tuesday.

BOSTON A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital suggested that the dietary supplement S-adenosylmethionine (SAMe) can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication, Pharmavite announced Tuesday.

“With each study, we continue to gain a better understanding of SAMe’s role in treating depression,” stated George Papakostas, associate professor of psychiatry at Harvard Medical School and lead author of the study. “This new finding, albeit preliminary and in urgent need of replication, suggests significant, clinically meaningful differences in outcome among patients who had SAMe added to their antidepressant medication treatment compared to those taking a placebo with their medication,” he said. “Continued research, however, is urgently needed to more definitively further our understanding of the role of SAMe in the treatment of adults diagnosed with depression. Adjunctive SAMe therapy is promising, but cannot yet be recommended for widespread clinical use.”

The first-of-its-kind study was published in the August 2010 American Journal of Psychiatry. According to the National Institute of Mental Health, there are approximately 14.8 million people with major depressive disorders in the United States.

 

The National Institute of Mental Health funded the study.

 

 

Pharmavite, manufacturer of Nature Made SAM-e Complete, provided the SAMe supplements and placebo pills used in the study.

 

 

The study, "S-adenosylmethionine (SAMe) Augmentation of Serotonin Reuptake Inhibitors for Antidepressant Nonresponders With Major Depressive Disorder: A Double-Blind, Randomized Clinical Trial," is the first randomized, placebo-controlled clinical trial conducted on SAMe in a population of patients with major depressive disorders. A total of 73 adults were enrolled in this six -week study and randomly assigned to the placebo control group or the SAMe treatment group. SAMe, in combination with standard depression treatment, was more effective than antidepressant treatment alone in improving measures of depression and remission rates of patients with significant clinical depression. SAMe-treated subjects had a greater response and remission rate to treatment than the placebo-treated group. SAMe was well-tolerated with no reported adverse reactions.

 

 

To date, at least 40 clinical trials have been conducted on SAMe directly and in combination with traditional antidepressant medications. Studies have evaluated SAMe’s use in naturally restoring a healthy mood to the most recent research for treating major depressive disorders. This current study follows a pilot study published in 2004 in the Journal of Clinical Psychopharmacology, which concluded that antidepressants used in combination with SAMe were significantly more effective in relieving depression than medication alone.

 

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