Nanotherapeutics Gets FDA Orphan-Drug Status for NanoDTPA™ Capsules to Treat Radiation Exposure

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FDA approves orphan-drug designation to Nanotherapeutics’ new oral capsule under development for treatment of radiation exposure. NanoDTPA™ capsule is one of several products the company is developing for chemical, biological, radiological and nuclear (CBRN) medical countermeasures.

Nanotherapeutics, Inc. announced today that NanoDTPA™ capsule, the company’s new oral product under development for treatment of known or suspected cases of internal contamination from exposure to radioactive plutonium, americium, or curium, was granted orphan-drug designation by the FDA Office of Orphan Products Development (OOPD). NanoDTPA™ capsule is one of several products in Nanotherapeutics’ product pipeline being developed for chemical, biological, radiological and nuclear (CBRN) medical countermeasures.

NanoDTPA™ capsule incorporates diethylenetriamine pentacetic acid (DTPA) in a novel orally-bioavailable formulation, as an alternative to the FDA approved injectable Ca-DTPA and Zn-DTPA products. NanoDTPA™ capsule allows DTPA to be absorbed from the gastrointestinal tract, offering a less invasive route of drug administration. Nanotherapeutics is also investigating NanoDTPA™ capsule for its potential as an iron chelation product in the treatment of iron overload, which results from repeated blood transfusions for the treatment of beta-thalassemia, myelodysplastic syndromes, and Sickle Cell Disease.

Orphan designation covers only drugs and biologics for treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. A company must file an application requesting orphan status, which the FDA can reject or approve. Orphan status provides such benefits as market exclusivity for seven years.

The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) provided initial funding to develop the NanoDTPA™ capsule oral product.

Nanotherapeutics, Inc. is a privately held biopharmaceutical company with a major focus on developing a diversified proprietary pipeline of products having both biodefense and medical applications. Products under development include biodefense, CNS, wound healing, addiction and pain, oncology, anti-infectives and orthopedics. The Company has one FDA-approved injectable biologic NanoFUSE® DBM used by orthopedic surgeons as bone graft filler. Nanotherapeutics has in-house cGMP manufacturing, formulation, and expertise in pre-clinical and clinical product development as well as clinical trial management to support its products. Established eleven years ago, the Company employs several proprietary platform technologies to manipulate and enhance the properties of drug candidates. For more information, visit the Company website at http://www.nanotherapeutics.com.

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Gary A. Ascani