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GT Biopharma starts making carbamazepine tabets for planned trials

By Gareth Macdonald contact

- Last updated on GMT

Gettyimages/Kenishirotie
Gettyimages/Kenishirotie

Related tags: Pharmacology

GT Biopharma Inc. has started making a non-opioid pain drug that uses a formulation technology licensed from Accu-Break Pharmaceuticals Inc.

The drug – known as Painbrake (carbamazepine) – is designed to treat chronic pain associated with conditions like diabetic neuropathy, post-herpetic neuralgia, trauma and multiple sclerosis.

The formulation – which is being made on GT’s behalf by a contract manufacturing organisation (CMO) – formulated using a technology developed by Accu-Break that allows tablets to be precisely broken into smaller pieces.

The technology is based on layers. The top layer contains the active pharmaceutical ingredient (API) while the lower layer acts as a stable region that controls where the tablet breaks using pre divided sections.

The aim is to provide patients and the doctors with a way of precisely controlling dosing.

Last month GT said it planned to submit the formulation for regulatory review in the next 18 months and that it would begin clinical trials next year.

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