Indivior gets drug approvals on both sides of Atlantic

Indivior confirmed receiving two separate drug approvals on Monday, from both the ANSM in France for its 'NALSCUE' product, and the FDA in the US over its RBP-6000 treatment.

It said the ‘NALSCUE’ nasal spray, intended for the emergency treatment of characterised or suspected opioid overdose - evidenced by respiratory depression and pending treatment in a medical department - received Marketing Authorisation from l'Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), the company announced on Monday.

The FTSE 250 firm said NALSCUE had been provided in France under a ‘temporary authorisation for use’ since July 2016.

“As opioid overdoses continue to have a profound impact on communities within France, NALSCUE may help make every second count by potentially allowing anyone, not just medical professionals, to administer life-saving treatment at the scene of an overdose," said the company’s chief medical officer Ponni Subbiah.

Indivior described NALSCUE as a “ready-to-use, needle-free, disposable delivery system” that was designed to deliver a dose of naloxone through the nasal mucosa of an opioid overdose victim, and allowed for rapid administration of the rescue medication.

It is supplied as a preassembled device that required “minimal training”, its board explained, so that a layperson could administer treatment to a characterized or suspected opioid overdose victim prior to the arrival of the emergency medical services.1,2

“Naloxone is an opioid receptor antagonist that effectively reverses the effects of natural and synthetic opioids for a period of time,” Indivior’s board explained in its statement.

“Naloxone, through injectable administration, has been used for opioid overdose treatment for over 40 years.”

Indivior said it is widely used by hospitals and emergency medical service personnel.

“NALSCUE is the first MA approved intranasal naloxone product for the emergency treatment of characterized or suspected opioid overdose in France.”

In France, there are 220,000 individuals with opioid use disorder as reported in 2013, the company noted.

Additionally, it said recent studies conducted by the European Monitoring Centre for Drugs and Drug Addiction had noted that between 10% and 23% of mortality among those aged 15 to 49 could be attributed to opioid use.

RBP-6000 gets favourable tick from the US FDA

In a separate announcement on Monday morning, Indivior also said that the US Food and Drug Administration had accepted - with a ‘priority review’ designation - its new drug application for the investigational once-monthly injectable buprenorphine ‘RBP-6000’.

The company said RBP-6000 was intended for the treatment of adults with moderate-to-severe opioid use disorder (OUD) as part of a complete treatment plan, to include counseling and psychosocial support.

Indivior said the NDA, which was submitted on 30 May, was based on data from the Phase 3 study assessing the efficacy and safety of RBP-6000.

“FDA acceptance with a priority review designation of our NDA application for RBP-6000 represents a significant milestone for our company as well as for the broader field of opioid use disorder treatment,” said Indivior chief executive Shaun Thaxter.

“This milestone is the result of our clear focus on developing treatments that deliver on the unmet needs of patients, along with our relentless advocacy for evidence-based medication-assisted treatment (MAT) as a key part of the addiction recovery equation.”

If approved, Indivior said RBP-6000 would represent the first once-monthly injectable buprenorphine treatment for OUD.

As a depot injectable formulation, RBP-6000 used a delivery system that was intended to make abuse and diversion difficult, the board said, and the product was intended to be administered by healthcare professionals only.

“We are excited about FDA's acceptance with priority review designation of our NDA application for RBP-6000, which we believe will represent an entirely new treatment paradigm if approved," said the company’s chief scientific officer Christian Heidbreder.

“We look forward to continuing to work closely with the agency as they review our new drug application and bring this potential innovative treatment option to patients and physicians.

“The FDA has set a PDUFA target action date of 30 November.”

Indivior said a priority review designation indicated the FDA's goal to take action on a new drug application within six months, compared to 10 months under standard review, and was assigned to medications that may offer “significant improvements” in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.

Additionally, the FDA reportedly notified the company that they would convene an advisory committee meeting to review the NDA for RBP-6000 as it met the 'new chemical entity/new combination product' criteria established by PDUFA IV .

As part of the NDA review process, the FDA was required to convene advisory committee meetings for all new chemical entities, unless they could provide adequate justification for not holding a meeting.

The FDA may need advisory committee input to assess the use of novel clinical or surrogate endpoints in the clinical trials or the overall benefit-risk of a new chemical entity, Indivior explained.

The advisory committee meeting for RBP-6000 will likely be convened in the fourth quarter, since the NDA had been assigned a priority review designation.