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New drug cleared by FDA for short-term treatment of acute pain

המידע מתוך medicontext.co.il

NEW YORK (Reuters Health) – Johnson & Johnson has received US Food and Drug Administration approval to market its Ultracet (tramadol HCl/acetaminophen) for short-term management of acute pain.

Ultracet is New Brunswick, New Jersey-based Johnson & Johnson's follow-up to the pain therapy Ultram (tramadol HCl). The drug, which will be marketed in the US by J&J company Ortho-McNeil Pharmaceutical Inc., is expected to launch in the fourth quarter.

J&J noted that the drug is a centrally acting analgesic and controls pain via a different mechanism of action than nonsteroidal anti-inflammatory drugs. It also said that the drug does not compromise the efficacy of certain antihypertensive agents, which has been the case with NSAIDs and COX-2 inhibitors.

However, the firm noted that there have been cases of abuse and dependence reported among users of the drug's active ingredient, tramadol. As a result, Ultracet is not recommended for patients with a history of drug or alcohol abuse or dependence, or for patients with a history of chronic opioid use.

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