BKK: Commercializing a New Drug

Abstract

Dr. Brad Worthington, surgeon and anesthesiologist, has created BKK, a nonopioid surgical pain reliever. A combination of three FDA-approved drugs, BKK has beneficial properties beyond those of the individual medications of which it is made. Having obtained a patent for BKK, Worthington and his business partner, Thurman Ballard, are evaluating three paths to market, each with its own risks, costs, timelines, and possible outcomes: 1) seek venture capital investment to fund a New Drug Application for FDA approval; 2) partner with a compounding pharmacy that can manufacture and distribute the drug wholesale; or 3) develop a relationship with a manufacturer that can produce convenience kits containing all three drugs, bottled separately, with directions for mixing and administering them.This case provides a close look into the barriers to entry for new drug commercialization for an individual or small business. Innovations in healthcare delivery, medical technology, and even new drug development or new uses for existing drugs are often generated by those closest to patient carenurses, doctors, and other medical personnel. But without significant resources, even the most ingenious new ideas require entrepreneurial thinking to bring them to market. Students have the opportunity to build a decision tree and explore the qualitative and quantitative data presented to justify all three options. Which should Worthington and Ballard choose? Excerpt UVA-QA-0909 Rev. Jan. 15, 2021 BKK: Commercializing a New Drug The Decision Dr. Brad Worthington and his friend, Thurman Ballard, needed to pull the trigger on a business decision. The choice was agonizing. It was January 2018, and Worthington had spent most of the last 18 years developing, using in his anesthesia practice, and teaching others how to use BKK, his unique and proprietary formulation of nonopioid anesthesia drugs. Worthington had created BKK by combining three other drugs approved by the US Food and Drug Administration (FDA)bupivacaine, ketorolac, and ketamineto form a locally infiltrated pain reliever at the surgical site that worked for up to 40 hours. Bupivacaine was a local anesthetic sometimes used as a nerve block; ketorolac was a nonsteroidal anti-inflammatory drug (NSAID); and ketamine was a common anesthesia drug with a long and safe history. When ketamine was administered in subanesthetic doses, it was currently the best-known drug for pain relief. The unique combination in BKK had many benefits. It prevented nausea and inflammationinflammation was the cause of a significant portion of a surgical patient's painand worked so well that it greatly reduced and often eliminated the patient's need to take opioid pain relievers during and after surgery. Some peers found it hard to believe, but even patients who had undergone complicated back, neck, and joint surgeries, which normally required one- or two-night inpatient stays, reported reduced opioid use and went home shortly after surgery. Many patients did not need any opioids after their procedures. . . .