Indivior’s opioid addiction treatment recommended by FDA advisory panel
pharmafile | November 1, 2017 | News story | Research and Development, Sales and Marketing |Â Â FDA, RGP-6000, Trump, US, indivior, opioid crisis, opioidsÂ
Another step has been made in the fight back against the ongoing opioid crisis in the US as it emerges that an experimental drug from Indivior which is designed to treat opioid addiction has been recommended by an advisory panel to the FDA, meaning full approval may not be far behind.
The crisis facing the US is one of its most crucial health imperatives, with President Trump recently declaring the matter a national public health emergency. 33,000 people died as a result of opioid addiction in the US in 2015 alone.
The panel evaluated the drug based on evidence generated by trials in which Indivior tested two dosing regimens: in one, patients were given 300mgs once a month for six months, and in another, patients were given 300mgs for the first two months, followed by 100mgs for the next four.
Based on these data, the panel voted 18-1 to recommend the use of RBP-6000 based on its potential benefits in treating opioid addiction, with the lower of the two available doses producing an acceptable safety profile for patients.
The FDA will make its final decision whether or not to approve the drug on 30 November, and while the regulator is not bound to the recommendations of regulatory bodies, it has historically followed them. If approved, Indivior’s therapy would be the first available monthly injectable buprenorphine treatment.
Matt Fellows
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