Inc., a privately held specialty biopharmaceutical company, announced that
it has it has submitted an Investigational New Drug (IND) application to the
FDA for a Phase I clinical studies to assess the safety and pharmacokinetics
of NanoBUP buprenorphine / naloxone capsule for the treatment of opiate
addiction. NanoBUP is a stable, oral swallowed capsule containing buprenorphine
/ naloxone developed with the company's proprietary NanoDRY particle
delivery system. This new product is an immediate release capsule that allows
buprenorphine to be absorbed more efficiently from the upper gastrointestinal
tract upon ingestion, offering a less invasive route of administration and potentially
reducing patient-to-patient variability.
Development has been funded through a National Institutes of Health -
National Institute of Drug Addiction (NIH-NIDA) small business innovative research
(SBIR) contract #HHSN271200577414C.
Buprenorphine is used in the treatment of moderate and severe acute and chronic
pain as well as opioid addiction. Naloxone is a drug used to counter the effects
of opioid overdose and is intended to render the product less able to be abused
by deterring intravenous injection. Sublingual delivery is currently available
using Suboxone (buprenorphine HCl/naloxone HCI dihydrate), but absorption
may be variable and lowered if swallowed too early.
Nanotherapeutics has entered a manufacturing and supply agreement for opioid-based
active pharmaceutical ingredients with Noramco, Inc., The agreement includes
the supply of buprenorphine hydrochloride, one of the active ingredients in
NanoBUP. Noramco, Inc. is a leading supplier of opioid-based active ingredients
for generic and branded pharmaceutical products.
NanoDOX for Diabetic Foot Ulcers and Wound Care Advances in Clinical
Advances in the clinical program of NanoDOX, the company's lead
product in development, include recruitment of patients in a Phase IIa clinical
study at the North Florida/South Georgia Veteran's Health System and a
collaboration with Walter Reed Army Medical Center.
The company has begun recruiting patients for a phase IIa clinical study of
NanoDOX 1% Doxycycline Monohydrate Hydrogel, a topical formulation of
doxycycline for chronic wounds. The randomized double-blind study will assess
the safety and efficacy of the product on healing of non-infected diabetic ulcers
of the lower extremities. The study is being conducted at the Gainesville, Florida
Veteran's Administration Hospital under the direction of the study's
principal investigator, Robert Feezor, MD. The study is partially funded by
an NIH grant 1R15NR009377-01 (Joyce Stechmiller, Ph.D. ARNP FAAN, grant PI).
Nanotherapeutics has entered into a Cooperative Research and Development Agreement
(CRADA) with the North Florida/South Georgia Veterans Health System to conduct
the phase IIa clinical trial, "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,"
at the Malcom Randall VA Medical Center in Gainesville, Florida. Recruitment
for this clinical trial began in February 2009.
A pilot study with NanoDOX to treat dehisced surgical wounds is being
developed in collaboration with Walter Reed Army Medical Center through a Cooperative
Research and Development Agreement (CRADA). The study, "Double-Blinded,
Single-Site, Pilot Study of NanoDOX versus Placebo Hydrogel for Dehisced
Surgical Wounds," is expected to begin this summer, supported by funding
included in the Fiscal Year 2009 Department of Defense Appropriations Act.