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FDA panel backs Indivior’s drug to fight opioid addiction

The former RB pharma unit hopes for sales in the $1bn region

IndiviorIndivior is on course to bring a new drug to market to tackle painkiller addiction in the US, offsetting the risks to its business from generic competition.

An FDA advisory committee backed approval of Indivior’s RBP-6000 drug by a vote of eighteen to 1 yesterday, which could set up a positive FDA verdict due later this month. The UK-listed company - formerly the pharma unit of Reckitt Benckiser - is hoping for sales in the region of $1bn for the new product.

That would help counteract a major setback for the business in the US a few weeks back when it lost a patent infringement lawsuit involving its main product Suboxone (buprenorphine and naloxone), another treatment for opioid dependence, and which raised the threat of low-cost copies reaching the market earlier than expected.

Indivior could see competition to RBP-6000 quickly however, as Camurus and Braeburn Pharma’s formulation of the drug (called CAM2038) can be delivered either weekly or monthly and has also just been backed by the FDA advisory committee by seventeen votes to 3.

RBP-6000 is a long-acting form of buprenorphine that can be delivered once a month, in contrast to Suboxone which is given as a film that dissolves under the tongue or in the cheek once a day. Generic once-daily tablet formulations of the drug are also available.

The FDA panel agreed that the lower of two doses filed for approval by the FDA had an acceptable safety profile, but said that they would like to see more data on who would benefit from the higher dose. Both regimens involve two doses of 300mg for two months, with the option then to either reduce the dose to 100mg for another four months or stay at the 300mg level for that period. Panellists suggested there was little difference in efficacy between the two doses.

Analysts have suggested that Suboxone has about 56% of the buprenorphine market, and that strong position could help facilitate rapid take-up of RBP-6000 if the FDA follows its panel’s advice and approves the new drug.

Opioid abuse has become such an acute problem in the US that President Trump signed an executive order last week to elevate the situation to the status of a public health emergency, while FDA Commissioner Scott Gottlieb has announced plans to make less harmful replacement opioids such as methadone and buprenorphine more accessible to addicts.

Around two million Americans are thought to be addicted to opioid painkillers, with overdoses claiming lives at the rate of around 175 each day last year.

Article by
Phil Taylor

2nd November 2017

From: Regulatory



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