BPI aims first to capture a share of the $1.4 billion U.S. market potential for multi-day, non-opioid pain relief after wisdom tooth and other dental surgical procedures. Target improvements over current products include three days of analgesia, low toxicity, less need for opioids, and convenient packaging in standard dental cartridges.
Studies show that 94% of patients currently receive an opioid prescription following a wisdom tooth extraction1 and an alarming 14 times greater risk of opioid abuse following those prescriptions.2
As the nation continues to grapple with the ongoing opioid epidemic, Balanced Pharma believes adding Enduracaine Dental to its development pipeline will expand its offering of improved pain management tools for dental professionals, and hopes to significantly reduce the number of opioid prescriptions.
Enduracaine is a patented combination of tetracaine 0.2%, lidocaine 0.4%, and epinephrine 1:250,000 introduced to the surgical market in 2023 as Endura-KT (a compounding kit) by Ventis Pharma. While the drug performance has been well received by practitioners in multiple specialties, including Oral & Maxillofacial Surgery, the kit presentation of the product has usability challenges including a short shelf-life and the need for refrigeration and reconstitution. For dental surgeons, incompatibility with standard dental syringes is a further barrier to rapid adoption.
BPI will use their patented technology to provide Enduracaine Dental in a standard dental cartridge, with a two-year shelf-life and no need for reconstitution or refrigeration.
“If we can give doctors a safe, non-opioid drug with three days of analgesia for their patients, in a standard dental cartridge that is efficient for their practice, that is an absolute win,” says BPI CEO Dr. Scott Keadle, a retired dentist.
“We are pleased to partner with Balanced Pharma to make our Enduracaine™ local anesthetic easier to use for dental surgeons,” says Dr. Lou Stanfield, Chief Scientific Officer at Ventis Pharma. “The Ventis drug delivered in the BPI cartridge is just what the doctor ordered, and we look forward to rapid adoption of this new product presentation by our current dental customers and across the dental surgical indication.”
Dr. Keadle adds, “We are honored to partner with Ventis Pharma and dental professionals to offer patients and families the chance to lower the risk of pain and opioid associated problems after dental surgery.”
Enduracaine Dental and all BPI products are currently in development, have not yet been approved by the FDA, and are not available for marketing or sale in the United States.
BPI intends to make Enduracaine Dental available to dental professionals within the next 12 months.
About Balanced Pharma, Inc.
Balanced Pharma, Inc. (BPI) is a pharmaceutical company based in Cornelius, North Carolina, focused on patient comfort and safety, and is currently developing BPI-001 and BPI-002, which are intended to reduce injection pain, speed the onset of anesthesia, and increase the success rate of local anesthetic injections. Enduracaine Dental (BPI-004) will add to the list of BPI products that are currently in development.
All BPI products are currently in development, have not been approved by the FDA, and are not available for marketing or sale in the United States.
Website: https://balancedpharma.com
BPI products have not yet been approved by the FDA and are not available for sale.
About Ventis Pharma
Website: https://ventispharma.com
References
1. “100 Million Prescription Opioids Go Unused Each Year Following Wisdom Teeth Removal,” Penn Medicine News, September 22, 2016
2. “Study: Dental painkillers may put young people at risk of opioid addiction,” The Washington Post, Ronnie Cohen, December 3, 2018
