Tonix Pharmaceuticals Holdings Corp (NASDAQ:TNXP) has posted two posters for the 2020 Annual American Society of Clinical Psychopharmacology meeting expected to be held between May 29 and May 30, 2020.
Tonix’s two posters to discuss TNX-102 SL and TNX-601 CR
One of the posters is titled “Pharmacokinetic Results of Dose Proportionality and Food Effect Study of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL).” The poster includes the pharmacokinetics analyses of TNX-102 SL as a treatment for alcohol use disorder, fibromyalgia, agitation in Alzheimer’s disease, and post-traumatic stress disorder. In the test of TNX-102 SL sixteen healthy volunteers aged between 18 and 65 years received a single dose of 2.8mg of TNX-102 SL fasted, TNX-102 SL 5.6mg fed, and TNX-102 SL 5.6mg fasted in a randomized 3-way crossover using a standard high fat meal.
The other poster is titled “Phase 1 Pharmacokinetic Study of a Once-Daily Formulation of TNX-601 CR (Tianeptine Oxalate Controlled-Release) Tablets.” It also includes TNX-601 CR pharmacokinetic analyses in the treatment of corticosteroid-induced cognitive dysfunction and major depressive disorder. This is an open-label, single-center, and sequential period trial with a single cohort of 12 healthy female and male volunteers. The volunteers received 13.1mg TNX-601, 39.4mg TNX-601 CR in a fasted state, 12.5mg tianeptine sodium as well as TNX-601 CR in fed states through a standard high fat meal.
Pharmacokinetic results of TNX-102 SL and TNX-601 CR
Tonix’s chief medical officer Gregory Sullivan indicated that based on the pharmacokinetics results from TNX-102 SL the extent and absorption rate of CBP was enhanced in a dose-proportional way from 2.8mg to 5.6mg. However, there was no food effect observed in TNX-102 SL 5.6mg. As a result, the lack of food effect consistently shows transmucosal absorption following sublingual administration, which is expected to offer predictable plasma levels.
On the other hand, Sullivan stated that TNX-601 CR PK results showed ideal once per day dosing with less food effect. The dosage was tolerated well without any side effects, and the profiles showed consistency with the former US marketed tianeptine given thrice daily.