Both boards have unanimously approved the deal and the companies expect to complete the transaction in the first quarter of 2023, pending approval from shareholders and clearance from US antitrust regulators.

"Our work in combating addiction has never been more critical, with overdose deaths in the US occurring at near record numbers,” said Indivior CEO Mark Crossley. “The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing US opioid and overdose epidemic and extends our leadership position in addiction treatments.”

Opiant’s lead candidate is OPNT003, a potential treatment for opioid overdose, including synthetic opiates, such as fentanyl, which Indivior said accounted for more than 75% of reported overdose deaths in the US in the twelve-month period ending April 2021.

OPNT003 was granted Fast Track Designation by the Food and Drug Administration (FDA) in November 2021 and Opiant expects to submit a new drug application in the final quarter of 2022. Subject to FDA clearance, approval for a fast-track application is expected in the third quarter of 2023, with launch in the US anticipated in the ensuing months.

Indivior said OPNT003’s unique clinical profile supports its potential to deliver annual net revenue of between $150 million and $250 million.

Other treatments in Opiant’s pipeline include OPNT002 nasal naltrexone, which is currently in a Phase 2 trial to assess its potential for treating alcohol abuse, plus OPNT004, a CB-1 agonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose.

The deal also gives Indivior access to Narcan, a nasal spray that is the current standard of care for reversing opioid overdose. Opiant (as Lightlake Therapeutics) developed Narcan in collaboration with the National Institute on Drug Abuse.

In July 2020, Indivior and subsidiary Indivior Solutions agreed to pay $600 million to resolve criminal and civil liberties associated with false claims related to the marketing of opioid-addiction drug Suboxone. The sum was on top of a $1.4 billion resolution in 2019 with Indivior’s former parent Reckitt Benckiser and a plea deal with Indivior’s former CEO Shaun Thaxter that saw him sentenced to six-months imprisonment in October 2020.

The Department of Justice said the total sum of more than $2 billion was the largest-ever resolution in a case it had brought involving an opioid drug.

Author: Elaine Burridge, Freelance Journalist