Bridge Therapeutics has developed BT-219 (buprenorphine and naloxone), an investigational treatment for opioid addiction, and formulated the candidate using Catalent’s orally disintegrating tablet (ODT) technology, known as Zydis.
The latter company announced that it has completed the clinical production of the drug, and signed an exclusive licensing agreement with Bridge on Zydis for the future manufacturing needs of the candidate.
In November, Bridge announced plans to submit a new drug application to the US Food and Drug Administration (FDA) ‘in the coming months’, after having received positive feedback during a pre-investigational new drug meeting with the regulatory agency.
BT-219 contains the same active ingredients as Suboxone, which is marketed by Indivior, only it would be administered with the advantages of Zydis ODT technology.
Zydis technology enables the production of a freeze-dried, sublingual tablet which disperses almost instantly in the mouth without water, offering improved patient compliance, adherence and convenience, due to taste masking and increased drug load potential, according to Catalent.
Moreover, Greg Sullivan, chief medical officer of Bridge, commented that utilizing the Zydis formulation technology “lessens the chance of an institutionalized patient being able to divert the medication for untoward purposes.”
The companies announced that Bridge’s exclusive license of the Zydis delivery technology will initially apply to the US, with the potential to expand to other nations.
Catalent’s Zydis development and manufacturing operations take place at the company’s facilities in Swindon, UK, with over one billion tablets being produced annually. According to Jonathan Arnold, president of Catalent’s Oral and Specialty Delivery business unit, over 36 products have been launched using Zydis technology in over 60 countries, to date.
According to Bridge, buprenorphine is considered safer and less addictive than methadone as a treatment for opioid addiction, a crisis that has placed the US in national emergency since 2017, with an average of 130 Americans losing their lives every day.
The FDA has been supporting the development of opioid reversal drugs, as well as the approval of generics to make the treatments more accessible.