Nanotherapeutics, Inc., a
privately held specialty biopharmaceutical company, announced that NanoBUP
Oral Buprenorphine / Naloxone Capsule, for treating opiate addiction, demonstrated
strong oral absorption in a Phase Ia clinical trial. The 2 x 2mg capsule achieved
significant oral bioavailability of 60 to 70 percent, in comparison to sublingual
administration of buprenorphine/naloxone at a similar dose, as reported in published
scientific reports. NanoBUP is a stable, swallowed capsule containing
buprenorphine / naloxone developed with the Company's proprietary NanoDRY®
particle delivery system. The product is an immediate release capsule that allows
buprenorphine to be absorbed more efficiently from the upper gastrointestinal
tract, offering an improved route of administration over currently available
The Phase Ia clinical program investigated the absorption of the NanoBUP
capsule from the upper gastrointestinal tract in healthy volunteers. The results
were favorable showing good bioavailability and safety. The peak plasma concentration
(Cmax) for buprenorphine was lower for NanoBUP, but the time to peak
concentration (Tmax) was similar to sublingual administration of buprenorphine/naloxone.
There were no major side effects. Development has been funded through a National
Institutes of Health – National Institute of Drug Addiction (NIH-NIDA)
small business innovative research (SBIR) contract.
In other clinical updates, a Phase IIa clinical trial of NanoDOX 1%
Doxycycline Monohydrate Hydrogel, a topical formulation of doxycycline for chronic
wounds, has been enrolling patients since February 2009 and is expected to be
completed by fourth quarter 2009. The study, “A Randomized, Double-Blind
Study to Evaluate the Safety and Efficacy of NanoDOX 1.0% Doxycycline
Monohydrate Hydrogel in Diabetic Adult Subjects with Lower Extremity Ulcers
Compared to Placebo Hydrogel”, will enroll 40 patients at the Malcom Randall
VA Medical Center in Gainesville, Florida.
The FDA has given approval for the Company to conduct a pilot study to treat
dehisced surgical wounds with NanoDOX Hydrogel. The Company will conduct
the clinical trial with investigators at the Walter Reed Army Medical Center.
The study, “A Double-Blinded, Single-Site, Pilot Study of NanoDOX
versus Placebo Hydrogel for Dehisced Surgical Wounds,” is expected to
begin at the end of 2009. The study is supported by funding included in the
Department of Defense FY 2009 Appropriations Act.