Tonix Pharmaceuticals (NASDAQ: TNXP) has announced that the American College of Clinical Pharmacology (ACCP) journal Clinical Pharmacology in Drug Development published results from clinical pharmacokinetic (PK) studies of its FDA-approved TONMYA, investigated as TNX-102 SL for the treatment of fibromyalgia in adults.
The paper is titled Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers.”
In a statement, Seth Lederman, MD, CEO of Tonix, commented, “These data demonstrate the importance of the proprietary basifying agent in TONMYA’s sublingual formulation. An earlier study conducted by Tonix showed that transmucosal delivery cannot be achieved by simply applying a liquid cyclobenzaprine HCl formulation under the tongue. Due to the basifying agent ingredient, sublingual TONMYA achieves rapid transmucosal absorption that bypasses first-pass hepatic metabolism. This pharmacokinetic profile underpins TONMYA’s unique sublingual formulation, which is designed to increase parent drug exposure during sleep while reducing exposure and side effects to the long half-life, active metabolite.”
Dr. Lederman continued, “Bedtime oral swallowed cyclobenzaprine was one of the first drugs studied as a treatment for fibromyalgia, but it failed because the benefits were only transient (~1 month) and fibromyalgia is a chronic condition requiring durable responses. Our design objective for TONMYA was to improve the durability of cyclobenzaprine’s treatment effect by decreasing liver production of the major active metabolite norcyclobenzaprine, which we believe counteracted the benefits of swallowed cyclobenzaprine over time. We believe the clinical pharmacology studies published in Clinical Pharmacology in Drug Development, show that TONMYA achieved this design objective. Later studies confirmed that TONMYA as a daily bedtime medicine provides a durable analgesic benefit to fibromyalgia patients and is generally well tolerated.”
