The company has announced it is working on at least four reformulation programs, “any one of which would be an important advance for medicine,” Dr. Lederman asserts. For PTSD, “We’re hoping to file an IND in the first quarter and launch Phase IIa trials in the second quarter.” Dr. Lederman adds.
The company met with the FDA and refined its protocol during the autumn. It also is advancing its alcohol program, TXN-301 and TNX-201 for tension headaches. “This is a significant problem, and patient offerings are limited,” Dr Lederman observes. “The only approved prescription drugs contain butalbital, a barbiturate.”
According to Dr. Lederman, the commonality in these conditions is that many of the available therapeutics either do not benefit or actually harm the patients: “Fibromyalgia and PTSD patients are treated with opiates, which lack sustained benefits and which many believe transform episodic events into chronic disease. Patients go to opiates in desperation.”
The key to fast absorption is the rapid disintegration formulation Tonix has developed. Rather than going through the digestive and circulatory systems, Tonix designed a delivery system that dissolves rapidly in the saliva under the tongue and crosses the mucus membrane.
“We’ve added an excipient that increases the pH of the saliva, making it more basic, thereby shifting equilibrium between the charged and uncharged form of cyclobenzaprine,” explains Dr. Lederman. “The uncharged form becomes slightly greater proportionally, and can go rapidly across the mucous membranes under the tongue.”
“We’re not looking for formulation challenges, but for big medical problems,” Dr. Lederman says. The company isn’t built around orphan drugs or orphan indications, and “that surprises people.” Instead, this microcap company repurposes existing therapeutics to meet unmet medical needs.
Fibromyalgia, for example affects five million people in the United States, and only about half are treated. PTSD affects 3–4% of Americans, and alcoholism is a very significant problem. All of Tonix’ programs are reformulations with 505b2 status. “By leveraging the existing safety information, we can be more bold and creative in targeting larger problems,” Dr. Lederman remarks.