: Expanded Access Policy

Expanded Access Policy

What is Expanded Access?

Expanded access, also called “compassionate use,” may be an option for individuals who do not qualify for enrollment in ongoing clinical trials to gain early access to investigational new drugs that are not yet approved by the US Food and Drug Administration (FDA) and for which evidence of safety and efficacy has not been confirmed. Individuals with serious or life-threatening conditions for which no other therapeutic options are available may be eligible for treatment through an expanded access program.

Investigational New Drugs Currently in Clinical Trials

Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve biodefense through developing potential medical counter-measures. Our lead product candidate, TNX-102 SL (cyclobenzaprine hydrochloride sublingual tablets), is in Phase 3 development as a bedtime treatment for fibromyalgia. Fibromyalgia is a chronic pain disorder characterized by chronic disability and overall high utilization of healthcare services, carrying significant social and economic costs as well as a heavy burden of human suffering.

At Tonix, we conduct randomized, controlled trials (RCTs) to study the safety and efficacy of our investigational new drugs. The safety and efficacy results from RCTs form the basis for regulatory authorities’ decisions on whether or not to approve new treatments. If approved, these treatments become widely available to the public and further empower physicians in treating their patients. We encourage patients to participate in clinical trials, both to help others with the same ailment and to contribute to greater scientific understanding of their disease and of the drugs being investigated as possible therapeutic alternatives.

Our Expanded Access Policy

Tonix does not currently offer investigational new drug TNX-102 SL for expanded access use. If you are suffering from fibromyalgia and are not eligible for our clinical trial, you can talk with your doctor about other available treatments, including FDA-approved medications for fibromyalgia. You can also visit www.clinicaltrials.gov to find other fibromyalgia clinical trials and see whether you are eligible to enroll in any of those trials.

Our expert development team is fully committed to bringing this innovative treatment to market as quickly as possible.

Our expanded access policy will be continuously reassessed, and any updates will be provided on our website. For further information, you can contact us at: investor.relations@tonixpharma.com. We will respond to any questions you may have within one week.

Thank you for your interest in Tonix Pharmaceuticals and in our investigational new drug, TNX-102 SL.