Balanced Pharma Inc. (BPI), a North Carolina-based company, has recently announced that France-based Septodont has made a strategic investment to support the commercialization of its new dental injection drugs.
BPI also said that Septodont COO Atif Zia has joined its Board of Directors.
“We are very proud to add Septodont to the growing list of dental industry members investing in the development of these important products and to have Atif [Zia] as part of our leadership team,” said Dr. Scott Keadle, a retired dentist and CEO of Balanced Pharma.
To date, BPI has raised about $6.5 million of its current $8-million funding round. When closed, this round will bring total investment in the company to approximately $12 million, including more than $9 million from dentists and other dental industry insiders.
The company’s goals include offering multi-day pain relief to reduce opioid use following orthopedic and oral surgery, as well as developing faster, less painful, and more reliable local anesthesia for dental procedures.
Flagship dental drugs: BPI-001 and BPI-002
Balanced Pharma’s flagship products, BPI-001 and BPI-002, are reformulated versions of the injectable anesthetics lidocaine and articaine. Both feature improved salt and acid balance to reduce pain, speed up onset, and enhance reliability.
The drugs will be packaged in standard dental cartridges, eliminating the need for new equipment or clinical protocol changes. The company plans to launch BPI-001 in the U.S. by the fourth quarter of 2027, followed by BPI-002 and expansion into global markets. BPI estimates the two products will compete in a U.S. retail market valued at $2.9 billion annually.
Non-opioid analgesic BPI-004
Another product, BPI-004, is a non-opioid injectable analgesic combining tetracaine (0.2%), lidocaine (0.4%), and epinephrine (1:250,000). When administered during surgery, BPI-004 is designed to provide up to three days of pain relief with low toxicity, minimal motor impairment, and reduced opioid reliance.
Balanced Pharma aims to bring BPI-004 to the U.S. market by the second quarter of 2025 under a 503(b) exemption. The company expects it to compete with bupivacaine and liposomal bupivacaine in the U.S. retail market, which is valued at $9 billion annually.
BPI’s proprietary technology platform was developed by a dentist and supports new injectable anesthetic and analgesic drugs for various applications, including orthopedic, general, and oral surgeries, as well as general dentistry.
Acquiring rights to non-opioid drug
The news comes amid the U.S. and Canadian opioid crisis. And this partly explains why BPI in November acquired the rights to Enduracaine Dental, a non-opioid injectable pain relief drug for post-surgical use in dentistry.
After all, dentists rank among the leading prescribers of opioids, having written more than 8.9 million opioid prescriptions in the United States in 2022, contributing to a heightened risk of dependency. Additionally, Canadians are the second-largest per-capita users of prescription opioids globally, consuming more than 34,000 daily doses (equivalent to 100 mg of morphine) per million people between 2013 and 2015. In comparison, the United Kingdom reported 12,000 daily doses per million people, Sweden reported 10,000, and Japan only 1,200.
