Indivior should soar on FDA approval for opioid treatment

Anticipating the US drug regulator to announce the approval of Indivior’s monthly injection for the treatment of opioid-use disorder by Thursday evening, analysts predict shares in the pharma company could surge around 20% on the news.

The US Food & Drug Administration's advisory committee recently made a strong recommendation for approval of RBP-6000 after Indivior worked closely with the FDA on the final stages of development of the treatment.

Broker Numis would be "flabbergasted" if if approval is denied, particularly given the regulator's recent tone and extensive work closely with the company to direct the parameters of the drug application.

With addiction to opioid based painkillers and heroin having reached "epidemic proportions" in the US, with more patients dying of overdoses than of HIV/AIDS at its peak, Numis said new treatment options are "clearly needed, and Indivior has conducted extensive scientific, dosing, efficacy and safety studies that support the approval of this important new drug".

"The shares could fall over 50% if the decision goes against Indivior, but we see this as highly unlikely," analyst Paul Cuddon predicted, reiterating his 'buy' recommendation.

Many City analysts are confident the advisory committee recommendation will see the FDA to support Indivior’s low dose and high doses, although Cuddon said the specific label was one remaining question to be resolved alongside approval.

Indivior's Suboxone film is the market leader in the field of treating opioid addiction for the past two decades, but Cuddon said medically-assisted treatment is still not widely accepted, with only a small percentage of US physicians registered to prescribe Suboxone.

"Adherence to a daily treatment is a major concern, as are the risks of misuse, diversion and unintended paediatric exposure. Indivior’s monthly depot addresses many of these issues, and based on the success of comparable products for the treatment of schizophrenia, we believe RBP-6000 has blockbuster potential," he said in a note to clients on Thursday morning, eyeing more than $1bn of peak sales.

Acknowledging that RBP-6000 is "not a perfect cure", the analysts said it does appear to significantly increase the abstinence rate in hard to treat patients and, coupled with psychosocial support and better awareness of the dangers of prescribing opioids, could help control what President Donald Trump has branded an "opioid crisis".