The synthetic THC product Marinol may be refilled up to five times in six months following the Drug Enforcement Administration's down-scheduling of its active ingredient.

Marinol (dronabinol), the oral dosage form of the Cannibas sativa (marijuana) active ingredient, was moved from a schedule II drug to a schedule III drug.

"Marinol has a potential for abuse less than the drugs or other substances in schedules I and II," the DEA concluded in a final rule published in the July 2 Federal Register.

DEA's decision was based on recommendations submitted by HHS, FDA and Unimed emphasizing that the low level of circulating THC from the oral dosage form, the slow onset of action and the low incidence of withdrawal result in only "moderate or low physical dependence," the administration said.

The transfer is the first time DEA has down-scheduled a schedule II drug, Marinol co-marketer Roxane reported.

Marinol NDA holder Unimed initially submitted a petition to the DEA for the transfer on Feb. 3, 1995. As part of its consideration process, DEA requested input from HHS in 1997.

A principal component of the HHS response was a document prepared by FDA entitled "Basis for the Recommendation for Rescheduling Marinol Capsules from schedule II to schedule III of the Controlled Substances Act." The document was enclosed with a Sept. 11, 1998 letter from HHS' Acting Assistant Secretary for Health recommending the transfer.

As part of its down-scheduling efforts, Unimed funded a research grant to the Haight Ashbury Free Clinics to highlight the low abuse potential of Marinol. The 1998 study of abuse potential, published in the April issue of the Journal of Psychoactive Drugs, concluded that due to the product's sesame oil encapsulation, "the onset of action is slow and gradual, it is at most only weakly reinforcing...and its effects are dysphoric and unappealing."

A survey of law enforcement personnel conducted as part of the study found no evidence of abuse or diversion of dronabinol, and a survey of healthcare providers found no detection of "script chasing" or "doctor shopping" among patients for whom the drug had been prescribed.

"There is no street market for dronabinol and no evidence of any diversion of dronabinol for sale as a street drug," the study concluded. "Dronabinol does not provide effects that are considered desirable in a drug of abuse."

The National Institute on Drug Abuse also submitted recommendations to DEA for down-scheduling, Roxane reported.

Following evaluation of the FDA/HHS documents, the DEA published a notice of proposed rulemaking in the Nov. 7, 1998 Federal Register to transfer Marinol from schedule II to schedule III. The notice received 10 comments from physicians, healthcare practitioners and patient organizations, nine of which supported the proposed rule, DEA reported.

Down-scheduling appears politically suitable in the climate of multiple ballot initiatives emerging across the U.S. advocating the use of marijuana for medical purposes. Roxane has played a role in educating advocates on both sides of the issue about the alternative THC source.

As a schedule III product, physicians are no longer required to write triplicate prescriptions for the treatment, and will also be able to call in new prescriptions. Pharmacies' record keeping requirements and distribution restrictions will also be eased as a result.

Patients currently taking Marinol, however, must obtain a new prescription to obtain refills, as scripts for the schedule III-designated product are now marked specifically as "non-refillable."

Though officially transferred to schedule III, the product will retain the import/export permit requirements of schedule II drugs as an extra level of protection, DEA specified.

Marinol has been available as an antiemetic following cancer chemotherapy since 1985, and marketed as an appetite stimulant for AIDS patients since 1992.

Roxane/Unimed Marinol Now Refillable Following DEA Down-Scheduling

More from Archive

More from Pink Sheet