Anavex announces development of oral tablet formulation for ANAVEX3-71 program

Anavex (AVXL) Life Sciences announced development of a once-daily oral tablet formulation for the ANAVEX3-71 program. The once-daily modified-release oral tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing. This achievement was confirmed in a Phase 1b clinical trial comparing the two dosage forms. The completed open-label, randomized study evaluated the pharmacokinetics and safety of immediate- and modified release formulations of ANAVEX3-71 administered orally in healthy male and female adults 18 years or older. Study results demonstrated a pharmacokinetic profile supportive of once-daily dosing with a safety profile consistent with prior ANAVEX3-71 studies. ANAVEX3-71 is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. ANAVEX3-71 has previously been studied in healthy volunteers prior to study ANAVEX3-71-002 and the Phase 2 study ANAVEX3-71-SZ-001. This novel mechanism of action offers the potential to treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics.