California Eases Prescribing Restrictions on Synthetic THC
Marinol is synthetic THC, the active ingredient found in marijuana; for this reason, it was originally classified as a Schedule II drug. Schedule II drugs are tightly controlled substances that require many prescribing restrictions such as triplicate prescriptions and no refills. The reclassification to a Schedule III drug will now allow doctors and patients in California easier access to the benefits of Marinol.
The decision to reschedule Marinol—made on the Federal level on July 2, 1999—was greatly influenced by the support of the Food and Drug Administration (FDA), the National Institute on Drug Abuse (NIDA), and the findings of a review study completed by the Haight Ashbury Free Clinics. This review concluded that Marinol has a low abuse potential and does not warrant being included in the same scheduling status as drugs such as morphine and oxycodone (other Schedule II drugs).
In clinical trials, and in use by thousands of patients, Marinol has been shown to stimulate appetite in significant numbers of patients. According to Gary Cohan, vice president of Pacific Oaks Medical Group (Beverly Hills, CA), a private medical practice devoted to HIV treatment and research, the drug works well with combination antiretroviral therapy and is highly effective in helping a patient get back his appetite. "With proper titration I can achieve the desired results with little or no side effects, and unlike marijuana, it can be used in a work setting, meaning that I can get my patients back to work and into their old routine again," he added.
Marinol was first brought onto the market by Roxane in 1985 for the treatment of cancer chemotherapy induced nausea and vomiting that is unresponsive to traditional medications. In 1992, the FDA approved Roxane and Unimed's supplemental new drug application for Marinol for the treatment of appetite loss or anorexia associated with weight loss in AIDS patients.
Roxane Laboratories Inc., a wholly owned subsidiary of Boehringer Ingelheim Corp., is a manufacturer of human pharmaceutical products with a strong commitment to palliative care.
Unimed Pharmaceuticals Inc., a wholly owned subsidiary of Solvay Pharmaceuticals Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV, and other infectious diseases.
For more information: Werner Gerstenberg, President and CEO, Roxane Laboratories Inc., 1809 Wilson Rd., Columbus, OH 43228. Tel: 614-276-4000. Fax: 614-308-0236.