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Knoll Pharmaceutical Receives Marketing Clearance For Vicoprofen.

MT. OLIVE, N.J.--(BW HealthWire)--Sept. 24, 1997--

First and Only Opioid/Ibuprofen Combination Product For

Treatment of Acute Pain is Now Available

Knoll(R) Pharmaceutical Co. announced today that it has received clearance from the US Food and Drug Administration (FDA) to market Vicoprofen(R) CIII (hydrocodone bitartrate(a) and ibuprofen tablets, 7.5 mg/200 mg).

Vicoprofen will be the first and only opioid/ibuprofen combination indicated for the treatment of acute pain and offers unique analgesic advantages including the additive effect of hydrocodone plus ibuprofen -- providing better pain relief than either of the components alone at the same doses.

In clinical studies, one tablet of Vicoprofen was as effective as two tablets of acetaminophen and codeine phosphate (300 mg/30 mg).

Vicoprofen is clinically proven to relieve acute pain in a broad range of applications including sprains/strains, post-surgery, back disorders, dental pain, sport injuries, and fractures/dislocations.

Vicoprofen has been shown to have excellent patient acceptance. The most common side effects were nausea (21.0%), sleepiness (22.0%), dizziness (14.0%), headache (27.0%), constipation (22.0%) and dyspepsia (12.0%).

Vicoprofen should not be given to patients in whom aspirin or other nonsteroidal anti-inflammatory drugs induce asthma, uriticaria, or other allergic-type reactions. Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). As with any opioid analgesic, the usual precautions should be observed regarding the impairment of mental and/or physical ability. These effects may be additive with alcohol and other Central Nervous System depressants.

According to the National Institutes of Health (NIH), an estimated 90 million Americans require treatment for pain at some point in their lives. In the United States, recurrent pain costs as much as $90 billion in doctor's fees, drugs, compensation, and litigation expenses each year.

Vicoprofen is the latest addition to Knoll's comprehensive line of pain management products including the Vicodin(R)(b) line, indicated for the relief of moderate to moderately severe pain and Dilaudid(R)(c) and Dilaudid HP(R)(d) for the treatment of moderate to severe pain which frequently affects patients with cancer and AIDS.

Earlier this year, Knoll entered into an agreement with ALZA Corp. for the development and worldwide commercialization of an innovative hydromorphone product which utilizes ALZA's advanced oral osmotic (OROS(R)) technology designed for the 24-hour management of severe chronic pain.

Knoll Pharmaceutical Co., headquartered in Mt. Olive, N.J., is the U.S. pharmaceutical unit of BASF Corp. and part of BASF Pharma, the global pharmaceutical division of BASF AG. Knoll Pharmaceutical Co. is dedicated to the development and marketing of prescription drugs for cardiovascular disease, pain management, endocrine, oncology, immune, thyroid disease and obesity.

(a) WARNING: May be habit forming.

(b) hydrocodone bitartrate and acetaminophen tablets, USP.

Warning: May be habit forming.

(c) hydromorphone HCL tablets, USP. 2 mg/4 mg/8 mg. Warning:

May be habit forming

hydromorphone HCL injection, USP. 1 mg/2 mg, 4 mg/mL.

Warning: May be habit forming.

(d) hydromorphone HCL injection, USP. 10 mg/mL injection.

Warning: May be habit forming.

CONTACT: Knoll Pharmaceutical Co., Mt. Olive

Linda Mayer, 973/426-5759
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Date:Sep 24, 1997
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