Duplex: New form of naltrexone approved by FDA

The Food and Drug Administration (FDA) has approved Pfizer’s new long-acting version of naltrexone hydrochloride, a drug that allows injection once a day and can be used to treat addiction. Naltrexone is Pfizer’s fourth…

Duplex: New form of naltrexone approved by FDA

The Food and Drug Administration (FDA) has approved Pfizer’s new long-acting version of naltrexone hydrochloride, a drug that allows injection once a day and can be used to treat addiction. Naltrexone is Pfizer’s fourth best-selling drug, and the new version of the compound, known as axitinib, is its most expensive: It costs more than twice as much as the previous version, which is injected just once a week. The brand-name version of naltrexone costs $29.99 per pill. The version approved by the FDA will have a wholesale cost of $428.99 per month.

The current generic versions of naltrexone cost significantly less: To inject naltrexone, users need only a syringe that costs less than $8.

U.S. officials told CNN they expect the new version of naltrexone to reduce hospitalizations and overdoses by addicts and will be a key part of treatment for opioid and heroin addiction.

The new version of naltrexone is a combined pill and injectable liquid version that will eliminate need for multiple injections, which are more likely to induce allergy reactions, and help treat the drug-seeking behaviour that often arises during addiction. The FDA has approved it for people who have attempted to break their addiction, and doctors can prescribe it to up to 12 patients at a time.

Pfizer had originally sought to launch the new naltrexone at the end of last year, but it received a preliminary rejection from the FDA. According to the company, it takes two years for an antidepressant medication to be approved if it is used to treat depression. Pfizer had anticipated that it would receive a green light for the new naltrexone around this time. In a filing with the SEC, the company said it also received U.S. government waivers for the new naltrexone product: The FDA cannot approve medicines for disorders without a unique new indication.

Aurora Biosciences, the biotech company that developed naltrexone, sold its rights to the drug for $100 million to Pfizer.

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