Catalent helps to advance new opioid addiction treatment
The fast-dispersing Zydis formulation could increase compliance with Medication-Assisted Treatment and thus better clinical outcomes.
Catalent has completed clinical production of Bridge Therapeutics' opioid addiction development therapeutic product, BT-219, and executed an Exclusive Licensing Agreement to use Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology.
Bridge currently intends to seek approval from the 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 is recognized as one of the world’s best performing ODTs and has well-established 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 US, 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, being 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,” commented 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, continued: “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.”
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance