PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Friday, 8 August 1997.

Brand Name: MARINOL(R)

Generic Name: dronabinol

Chemical Name: Delta-9-tetrahydrocannabinol or delta-9-THC.

Indication

MARINOL is approved for the following indications:

1. For nausea and vomitting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

2. For the treatment of anorexia associated with weight loss in patients with AIDS.

Dosage

MARINOL is supplied as round, soft, gelatin capsules containing either 2.5mg, 5mg, or 10mg dronabinol for oral administration.

Clinical Activity

Appetite Stimulation

The appetite stimulant effect of MARINOL for the treatment of AIDS-related anorexia was studied in a randomized, double blind, placebo-controlled study involving 139 patients.

As compared to placebo, MARINOL treatment (2.5mg, b.i.d, before lunch and supper) resulted in a statistically significant improvement in appetite at four weeks. Trends toward improved body weight and mood, and decreases in nausea were also seen. After completing the 6-week study, patients were allowed to continue treatment with MARINOL in an open-label study. The study showed a sustained improvement in appetite for a full twelve months, without the need to increase the dose.

Antiemetic

MARINOL treatment of chemotherapy-induced nausea and vomitting was evaluated in 454 patients with cancer, who received a total of 750 courses of treatment of various malignancies. The dosage for MARINOL to treat refractory nausea and vomitting is 5mg/m2.

Adverse Events

The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the central nervous system (CNS), and were generally mild, occurring in 33% of patients. About 25% of patients reported a minor CNS event during the first two weeks of therapy, and only about 4% reported such an event each week thereafter. The drop-out rates between patients

receiving placebo and MARINOL were similar for the AIDS-related anorexia indication dosed 2.5mg, b.i.d., before lunch and supper.

Although no drug/drug interactions were discovered during clinical trials for MARINOL, cannabinoids may interact with other drugs, including\ amphetamines, atropine, and amitriptyline.

Scheduling

MARINOL is currently a Class II scheduled drug. The same care in prescribing and accounting for MARINOL should be used as for other schedule II drugs. Prescriptions should be limited to the amount necessary for the period between visits. A request for rescheduling to Class III is under active consideration by the Drug Enforcement

Administration.

This request is based in part on a recent study conducted by the medical and research staff of the Haight Ashbury Free Clinic in San Francisco, sponsored by Unimed/Roxane Laboratories. This study found that the diversion potential of MARINOL is low.

Reimbursement

Information

MARINOL is reimbursed by all third party and government programs for its approved indications for cancer chemotherapy patients and for patients with AIDS. In addition, Roxane Laboratories has a patient assistance program to help cover the costs of MARINOL.

Physicians and patients seeking reimbursement and patient assistance program information can call 1-800-848-0120.

Medical

Information

For clinical and medical information physicians and patients can call Roxane Laboratories at 1-800-327-4865.

MARINOL(R) (dronabinol)

DRUG HISTORY

Drug

History

MARINOL(R) (dronabinol) was first approved in 1985 for the treatment of the nausea and vomitting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic (anti-nausea) treatments. The drug, which is available only in capsule form, is a synthetic form of delta-9-tetrahydrocannabinol (THC), the major active component of marijuana.

The drug is regulated under Schedule II of the Controlled Substances Act.

In 1992, the Food and Drug Administration (FDA) approved a supplemental new drug application (SNDA) for MARINOL for treatment of appetite loss or anorexia associated with weight loss in patients with AIDS. The drug had been in clinical trials for this indication since 1990.

Corporate

Information

Roxane Laboratories, Inc., of Columbus, Ohio, is the exclusive distributor of MARINOL in the United States. Unimed, Inc., of Buffalo Grove, Illinois, holds the NDA for dronabinol and co-promotes MARINOL with Roxane Laboratories.

Roxane Laboratories is a prescription specialty and generic pharmaceutical manufacturer located in Columbus, Ohio. The company has long specialized in products that relieve pain and discomfort for the seriously ill. The company was particularly interested in developing the additional indication for MARINOL's use by patients with AIDS because it fits into this emphasis. Roxane is a subsidiary of Boehringer Ingelheim Corporation of Ridgefield, Connecticut, and is a member of a worldwide group of Boehringer Ingelheim companies.

CONTACT: Peter Velasco, 202-944-5182, for Roxane Laboratories

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