Core Insights - TONMYA (cyclobenzaprine HCl sublingual tablets) is the first new FDA-approved treatment for fibromyalgia in adults in over 15 years, launched commercially in the U.S. in November 2025 [1] - The formulation is designed for rapid transmucosal absorption, bypassing first-pass liver metabolism, which enhances the durability of analgesic response compared to traditional oral cyclobenzaprine [1][2] - Clinical studies indicate that TONMYA provides a durable analgesic benefit and is generally well tolerated among fibromyalgia patients [2][5] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on central nervous system (CNS) and immunology treatments, with TONMYA as its flagship product [9] - The company is also developing other treatments, including those for major depressive disorder and acute stress disorder, leveraging its proprietary formulations [9] Product Details - TONMYA utilizes a patented sublingual formulation that enhances drug exposure during sleep while minimizing side effects associated with the active metabolite norcyclobenzaprine [8] - The product is indicated for the treatment of fibromyalgia in adults and is expected to have U.S. market exclusivity until 2034/2035 due to multiple patents [8] Clinical Study Findings - Study 1 demonstrated that the potassium phosphate dibasic formulation of TONMYA achieved a 154% relative bioavailability compared to oral immediate-release cyclobenzaprine, with a significantly shorter absorption lag [3] - Study 2 confirmed the absence of food effects on pharmacokinetic parameters and characterized the active metabolite's elimination half-life as approximately 60 hours [4] Market Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain and other debilitating symptoms [7] - There is a noted dissatisfaction with currently marketed products for fibromyalgia, highlighting the potential market opportunity for TONMYA [7]

Core Insights - Pasithea Therapeutics Corp. announced positive pharmacokinetic (PK) data for its oral MEK inhibitor PAS-004, indicating improved properties in tablet form compared to capsules [1][2] Pharmacokinetics (PK) - The tablet formulation of PAS-004 (4mg and 8mg cohorts) showed a Cmin of 37.6 ng/mL, with dose-normalized exposures approximately three times higher than the capsule formulation [2] - The 8mg tablet demonstrated an area under the curve (AUC) and Cmax slightly greater than the 22mg capsule, with less patient variability and a similar Tmax range [2] - Cohort 1 (4mg tablet) results: AUC of 1,120 ng·h/mL and Cmax of 58.1 ng/mL; Cohort 2 (8mg tablet) results: AUC of 2,290 ng·h/mL, Cmax of 118 ng/mL, and Cmin of 75.4 ng/mL [3] Company Overview - Pasithea Therapeutics is focused on developing PAS-004 for treating neurofibromatosis type 1-associated plexiform neurofibromas and other diseases, currently in Phase 1 clinical trials [6]

Core Insights - Annovis Bio, Inc. has published a new article in the peer-reviewed journal Biomolecules detailing the pharmacokinetic profile of a new crystal form of buntanetap, which is being developed for neurodegenerative diseases like Alzheimer's and Parkinson's [1][2]. Group 1: New Crystal Form of Buntanetap - The newly identified dihydrate crystal form of buntanetap offers greater stability compared to the original anhydrous form, which has been used in all previous studies [2]. - The publication confirms that the new crystal form maintains the pharmacokinetic profile and metabolism essential for the drug's therapeutic efficacy [2][4]. Group 2: Clinical Trials and Intellectual Property - The new crystal form of buntanetap is currently being utilized in a pivotal Phase 3 clinical trial (NCT06709014) for early Alzheimer's disease, with key readouts expected in Fall 2026 and Fall 2027 [4]. - This new form extends the intellectual property protection of the lead compound into the 2040s, covering its mechanism of action, therapeutic use, and potential combinations with other drugs [4]. Group 3: Company Commitment and Communication - The company emphasizes its commitment to rigorous analysis of buntanetap to ensure beneficial outcomes for patients [4]. - Annovis Bio is dedicated to developing innovative therapies aimed at improving patient outcomes and quality of life in neurodegenerative diseases [6].