NanoBUP™ Oral Swallowed Capsule - Phase 2 clinical program

Buprenorphine (CAS: 52485-79-7)

Partial mu opioid receptor agonist

Oral Swallowed Capsule - Phase 1 & 2 clinical studies

NanoBUP™, an innovative formulation that provides an easy-to-take, swallowed capsule dosage form, represents a breakthrough in buprenorphine delivery as a replacement for sublingual buprenorphine. Currently, oral buprenorphine is available as sublingual tablets, films, and buccal patches. NanoBUP™ oral swallowed buprenorphine capsule, initially developed under a National Institute on Drug Abuse (NIDA) Small Business Innovation Research (SBIR) contract, has been shown in multiple clinical studies to produce similar bioavailability with a lower Cmax compared to sublingual buprenorphine, which may promote less craving and improve weaning during maintenance therapy.

In addition, it may have lesser addiction risk compared to sublingual buprenorphine formulations. Although, organizations like the Substance Abuse and Mental Health Services Administration (SAMHSA), NIDA and the World Health Organization agree that medication-assisted treatment decreases opioid use, opioid related-deaths, and increases success in treatment, only an estimated one-third of patients have been found to easily access it. One way to increase availability is to create easier and more tolerable dosing options, such as the NanoBUP™ oral swallowed capsule.

NanoBUP™ Oral Swallowed Capsule has been tested in three Phase 1 clinical studies and one Phase 2 clinical study. NanoBUP™ Oral Swallowed Capsule is in Phase 2 clinical development.

Clinical Studies (Completed)

  • NCT01260675 Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone

  • NCT00880841 A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone

  • NCT02161354 Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars

Intellectual Property

Nanopharmaceutics holds world-wide exclusive rights to U.S. patents 8,377,479, 9,554,996, and related foreign filings.