GT Biopharma to Develop New PainBrake Tablet Formulation to Treat MS Neuropathic Pain

GT Biopharma has acquired licensing and development rights for PainBrake —  Accu-Break Pharmaceuticals’ non-opioid pain medication to treat dysesthesia and pain caused by nerve damage in multiple sclerosis (MS).

“I am looking forward to initiating the development of PainBrake as we anticipate that many patients with difficult-to-treat neuropathic pain could benefit from this product,” Kathleen Clarence-Smith, CEO of Tampa-based GT Biopharma, said in a press release.

Currently available pain relief medicines are only efficient in about half of patients, and for many, such medicines cause side effects like sleepiness, balance problems and risk of addiction.

PainBrake is not based on opioids or other potentially addictive components. Rather, it uses a patented delivery technology that is expected to minimize side effects while providing maximum pain relief. The tablets consist of a top layer with the pain-killer compound that is pre-divided by deep scoring into smaller, accurately dosed pieces. The new formulation also has a lower drug-free layer that provides a stable breaking region to split the tablets.

“We are delighted by the opportunity for our patented technology to provide a product that will treat such a critically important disease as neuropathic pain,” said Elliot F. Hahn, executive chairman of Accu-Break. “We are pleased to assist GT Biopharma in the development of this very important product.”

GT Biopharma — formerly known as Oxis International — expects regulatory entities to require only a few short clinical trials to win approval, since its tablet formulation is based on an already existing and approved pain medicine. GT Biopharma said a New Jersey company will manufacture the PainBrake tablets needed for the clinical trials.

The trials will begin in late 2018, and GT Biopharma expects to submit a new drug application to the U.S. Food and Drug Administration within 18 months.

“We are thrilled to take this key step toward commercialization of PainBrake, a non-opioid pain reliever that we believe will fulfill a significant need in the treatment of neuropathic pain,” said Anthony J. Cataldo, executive chairman at GT Biopharma.