Catalent has completed clinical production of Bridge Therapeutics Inc.’s opioid addiction therapeutic product, BT-219, and executed an Exclusive Licensing Agreement to use Catalent’s Zydis orally disintegrating tablet (ODT) technology. Bridge intends to seek approval from the U.S. FDA for BT-219 under the 505(b)(2) regulatory submission pathway as well as a possible future single entity buprenorphine product.

Catalent’s Zydis ODT technology is a unique, freeze-dried tablet that disperses almost instantly in the mouth without water. Zydis offers advantages over conventional oral dosage forms, including improved patient compliance, adherence and convenience. Bridge’s exclusive license of the Zydis technology will initially apply to the U.S., with the potential to expand to other nations.

BT-219, or Bunalz, is an investigational new drug (IND) which applies the Zydis delivery technology to buprenorphine and naloxone, which are the active ingredients in the Suboxone prescription medication for opioid addiction. Buprenorphine, a Schedule III medication, is considered safer and less addictive than methadone, which is classified as a Schedule II medication. It has also been shown that buprenorphine is six-times safer than methadone with regard to overdose risk among the general population.

“Catalent has a proven track record in working with partners to bring new therapies to market quickly and we look forward to working with Bridge as they pursue approval for this important and exciting new development product,” said Jonathan Arnold, president of Catalent’s Oral and Specialty Delivery business unit. He added, “The Zydis technology platform has been shown to be very versatile and effective in developing easy-to-administer dose forms for innovators and to date, more than 36 products have been launched using Zydis technology in over 60 countries.”

Dr. Greg Sullivan, chief medical officer of Bridge Therapeutics, said, “This new formulation will provide improved administration characteristics. With many formulations being unpleasant to patients, this fast-dispersing Zydis formulation could potentially increase compliance with Medication-Assisted Treatment (MAT) and thus better clinical outcomes”. He added, “In addition to assisting the needs of the general population, utilizing the Zydis formulation technology lessens the chance of an institutionalized patient being able to divert the medication for untoward purposes.”

Catalent’s 250,000 sq. ft. site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people. In March 2019, Catalent announced a $27 million investment to commercialize its next-generation ODT technology, Zydis Ultra, which allows an increased drug load and taste masking to be incorporated into the Zydis dosage form.