Tonix Pharmaceuticals Announces Plans for New Drug Application for Fibromyalgia Treatment

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Tonix Pharmaceuticals announced that it has agreed to terms with Rho Inc., a global contract research organization (CRO), to support its upcoming New Drug Application (NDA) to the FDA for Tonmya (cyclobenzaprine HCl sublingual tablets), to support patients with fibromyalgia. According to a company press release, the company is buoyed by promising Phase III study results and plans to meet with the FDA in the first half of the year, targeting an NDA submission in the latter half.¹

“We are excited by our most recent positive Phase III study results of Tonmya and look forward to Rho’s support in preparing our NDA,” said Seth Lederman, MD, president, CEO, Tonix Pharmaceuticals, in the aforementioned press release. “We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase III studies.”

At the end of last month, Tonix held a key opinion leader (KOL) webinar in order to discuss the encouraging trial results. Featuring insights from Daniel Clauw, MD and Lesley Arnold, MD, the webinar highlighted Tonmya as a non-opioid, non-addictive bedtime medication that significantly reduces daily pain and improves sleep quality, fatigue, and overall symptoms in fibromyalgia patients.²

“These data offer new hope for patients with fibromyalgia,” Arnold said in the release. “Many of my patients have required combination treatments to combat their multiple fibromyalgia-related symptoms. We haven’t seen a medication that can treat fatigue, sleep, and pain all together. Having a compound like Tonmya that may address all three is very exciting.”

According to the company, the positive outcomes from the RESILIENT study, including meeting all primary and key secondary endpoints with statistical significance, have positioned Tonmya as a possible first-line treatment option for fibromyalgia. The company also stated that it believes in the drug’s ability to address multiple fibromyalgia-related symptoms simultaneously, a notable advancement given the current need for combination therapies to manage the condition.²

“We believe that these positive results show that fibromyalgia can be successfully treated by Tonmya and may provide the opportunity for Tonix to have the first FDA-approved drug for fibromyalgia in more than a decade,” Lederman said in the release. “We are now an important step closer to bringing a new, first-line treatment to fibromyalgia patients that offers broad symptom relief and favorable tolerability for chronic use and adherence.”

References

1. Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Submission of New Drug Application to the FDA for Approval of Tonmya™ for the Management of Fibromyalgia. GlobeNewswire. February 13, 2024. Accessed February 16, 2024. https://www.globenewswire.com/en/news-release/2024/02/13/2828206/28908/en/Tonix-Pharmaceuticals-Announces-Engagement-of-Rho-as-CRO-to-Support-Submission-of-New-Drug-Application-to-the-FDA-for-Approval-of-Tonmya-for-the-Management-of-Fibromyalgia.html

2. Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyalgia Trial for Tonmya™, Plans to File NDA for FDA Approval in Second Half of 2024. Tonix Pharmaceuticals. February 14, 2024. Accessed February 16, 2024. https://ir.tonixpharma.com/news-events/press-releases/detail/1452/tonix-pharmaceuticals-hosted-kol-webinar-on-positive-phase