Short facts  
API Buprenorphine
Technology Oral
Indication Opioid use disorder
Development phase Preclinical
Expected filing with FDA -
In-house or partnership In-house

Unmet medical need

Today, buprenorphine products to treat opioid dependence are only available in sublingual/buccal tablets and film formulations which generally are less convenient than an oral administration route. As supervised treatment may be part of the patients care, e.g. for patients who receive treatment in methadone clinics, which is particularly common in Europe, the dissolve time can play a role in limiting patient access.

The concept

OX382 is being developed as an oral, swallowable formulation containing buprenorphine and naloxone for the treatment of opioid dependence. Buprenorphine is a partial opioid receptor agonist used in medically assisted treatment of opioid dependence to alleviate symptoms of withdrawal and naloxone, an opioid receptor antagonist, is part of the formulation as an abuse deterrent.

A swallowable formulation offers several advantages over currently available administrations routes for certain patient groups and treatment settings.