Unimed Pharmaceuticals Inc has become solely responsible for the marketing of Marinol CIII (dronabinol) capsules, effective January 1, 2001. Marinol is the only FDA approved synthetic form of tetra hydro cannabinol (THC).
Marinol was first brought onto the market for the treatment of cancer chemotherapy induced nausea and vomiting that is unresponsive to conventional medications. In 1992, the FDA approved 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 launched Marinol in 1987. In 1992, Unimed and Roxane Laboratories started co-promoting Marinol in the United States. Now, as sole marketer of Marinol, Unimed Pharmaceuticals assumes responsibility for all manufacturing, distribution, and marketing responsibilities for the product.
"Marinol has provided HIV and cancer patients nationwide a safe and effective treatment for anorexia and nausea," said Robert Dudley, president and CEO, Unimed Pharmaceuticals Inc. "Unimed looks forward to fully supporting the continuing education of health care providers and patients on the medical role of Marinol, including support of an indigent patient assistance program. Moreover, Unimed is currently exploring Marinol's use in additional therapeutic areas."
In 1999, the Drug Enforcement Agency (DEA) reclassified Marinol from a Schedule II to a Schedule III medication, indicating lower abuse and addiction potential and facilitating the prescription refill process. To date, 41 of 50 states have rescheduled Marinol in accordance with DEA actions, and efforts are underway to ensure the reclassification in all 50 states.
Marinol is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid or sesame oil. Patients receiving treatment with Marinol should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and perform such tasks safely.
Marinol should be used with caution in patients with cardiac disorders, a history of substance abuse, mania, depression, schizophrenia, or concomitant therapy with sedatives, hypnotics and other psychoactive drugs.