DRAXIS' Modafinil trial results are statistically significant; new treatment for Narcolepsy.

MISSISSAUGA, Ontario--(BUSINESS WIRE)--Feb. 28, 1996--DRAXIS Health Inc. (TSE:DAX;NASDAQ:DRAXF) Wednesday reported statistically significant results of its one-year long double-blind randomized placebo-controlled cross-over clinical study of Modafinil 200 mg and Modafinil 400 mg in the treatment of Narcolepsy.

Seventy-five patients were each studied over a six-week period during which each patient was given placebo, 200 mg or 400 mg of Modafinil in divided doses.

The primary end points were sleep latency (the time from lights out to sleep onset) during the Maintenance of Wakefulness Test (a daytime sleep laboratory test) and daily sleep episodes recorded in the patient dairy. Modafinil significantly increased the mean sleep latency (the time taken to fall asleep). The 200 mg dose was 40% better than placebo (p=.002) and the 400 mg dose was 54% better than placebo (p=.001). The 200 mg dose reduced the mean number of periods of sleep and severe somnolence by 24% (p=.013) and the 400 mg dose by 27% (p=.008).

Among those patients taking no stimulant medication prior to the study, a comparative decrease in excessive daytime somnolence was reported by 80% of the patients while on Modafinil 400 mg, 66% while on Modafinil 200 mg and 34% while on placebo. Among those patients treated with stimulants prior to the study the comparative differences were 53%, 50% and 25% for Modafinil 400 mg, Modafinil 200 mg and placebo respectively. Conversely, patients previously treated who reported deterioration while on the study were for placebo 58%, Modafinil 200 mg 25%, and Modafinil 400 mg 33%.

Using the Epworth Sleepiness Scale, Modafinil 200 mg (p=.018) and 400 mg (p=.009) both decreased the likelihood of falling asleep.

The Profile of Mood States (POMS) test was used to evaluate changes in mood, specifically tension-anxiety, anger-hostility, confusion-bewilderment, vigor-activity, and fatigue-inertia. Modafinil had no adverse effects on mood, with a single exception. Modafinil 400 mg slightly increased tension-anxiety compared to placebo (p=.028); but the scores were still well below both the pre-study scores and published normal scores for this factor. Vigor-activity increased after Modafinil 200 mg (p=.018) and 400 mg (p=.012).

Neither dose of Modafinil interfered with the patient's ability to sleep voluntarily during the day nor did either dose interfere with the quantity or quality of nocturnal sleep.

Only one patient dropped out of the study due to side effects of Modafinil. The principle side effects were headache, nausea, dry mouth, heartburn, diarrhea, and dizziness. The side effects were generally limited to the first few days of treatment.

Narcolepsy is a primary sleep disorder characterized by uncontrolled episodes of falling asleep at unexpected times and conditions. It affects approximately 0.05% to 0.1% of the population or approximately 14,800 to 29,600 Canadians. No new treatment for Narcolepsy has been approved in Canada since 1959.

The full results of this study will be used by the company to complete its submission for regulatory approval in Canada. This file is expected to be ready for submission to Canadian Health Regulatory authorities towards the end of 1996.

Modafinil is approved for the treatment of Narcolepsy in France. DRAXIS has an exclusive license to market and sell Modafinil in Canada. The licensor for the US, UK and Japan is Cephalon Inc. (NASDAQ:CEPH).

DRAXIS, is a marketing and research company that operates Canadian Neurological, Dermatological, and Veterinary pharmaceutical divisions, a U.S. consumer marketing company, and offers products exclusively through U.S. podiatrists.

CONTACT: DRAXIS Health Inc.

Kendall McAlister, Coordinator, External Relations

905/677-5500; Fax [phone]

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Canadian Investor Relations

Small-Cap Equity Investor Relations Ltd.

Robert Grahovar

416/535-4146

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U.S. Investor Relations

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Robert Kneeley, 954/351-1976