Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - October 23, 2000
Nausea and vomiting are common side effects associated with antiretroviral medications used to treat HIV infection. MARINOL, proven safe and effective in the treatment of anorexia or appetite loss associated with weight loss in people with AIDS, was chosen for this study due to its dual use as a safe and effective antiemetic for cancer patients undergoing chemotherapy. MARINOL is derived from synthetic THC, the active ingredient found in marijuana.
"Marinol has been shown to be effective as an anti-nausea agent for people with cancer undergoing chemotherapy," said Roger Anderson, MD, of Anderson Clinical Research, Pittsburgh, PA and lead investigator of the study. "The study results we present today show that Marinol may also be useful for patients experiencing nausea and vomiting associated with their HIV treatment.
This is important because side effects such as nausea and vomiting can often cause patients to miss doses of their antiretroviral medication."
The MAR 0698 study enrolled patients who were on stable antiretroviral therapy. Twenty-seven patients were randomized to receive MARINOL 2.5 mg twice-daily within one hour of taking their antiretroviral medication (14 patients) or MARINOL 5.0 mg at bedtime (13 patients) for six weeks. At study start and at six weeks patients were assessed by questionnaire for the number of minutes they did not feel well in the previous 48 hours, the number of episodes of vomiting and the severity of nausea in the same period.
Ninety-three percent (13/14) of patients in the MARINOL twice-daily group had a greater than 50% improvement in symptoms of nausea and vomiting, and 77% (10/13) of patients taking MARINOL at bedtime had a greater than 50% improvement. The severity of nausea improved by at least one grade in 96% (26/27) of patients and no severe or very severe nausea was experienced in either group after six weeks.
"Based on these findings, Marinol may have a significant impact on managing antiretroviral-associated nausea and vomiting," commented Dr. Anderson.
MARINOL is generally well-tolerated with side effects usually being mild and reversed by a lowering of the drug's dose. The most common side effects involve the central nervous system and include sleepiness, dizziness and euphoria (or giddiness).
MARINOL is marketed by Roxane Laboratories and co-promoted with Unimed Pharmaceuticals, Inc. MARINOL was first introduced onto the market by Roxane in 1986 for the treatment of cancer chemotherapy induced nausea and vomiting that is unresponsive to traditional medications. In 1992, the FDA approved a supplemental new drug application for MARINOL for the treatment of appetite loss or anorexia associated with weight loss in AIDS patients.
Roxane Laboratories, Inc. (http://www.roxane.com) is a leading manufacturer of ethical human pharmaceutical products with a strong commitment to HIV and palliative care. The Company is a wholly owned subsidiary of Boehringer Ingelheim Corporation, (http://us.boehringer-ingelheim.com) located in Ridgefield, CT, and is part of the Boehringer Ingelheim worldwide group of companies.
Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of cardiology, men's health, HIV and other infectious diseases. Unimed Pharmaceuticals, based in the Chicago, Illinois area, has expertise in ethical drug development, marketing and sales.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.
For more information on Roxane Laboratories or Marinol, please see http://www.marinol.com.
SOURCE Roxane Laboratories, Inc. Web Site: http://www.marinol.com
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