pp-175 Tablets, sublingual 5.6 mg
Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Major depressive disorder (MDD) — adults with inadequate response to standard antidepressants
Clinical stage: Phase 2
Modality: Small molecule (cyclobenzaprine HCl sublingual tablet)
Mechanism / Target: 5-HT2A antagonist and TCA-like multireceptor activity — at low sublingual dose, promotes slow-wave sleep and hypothesised neuroplasticity effects relevant to MDD
Route / form: Sublingual tablet (5.6 mg once nightly)
Differentiation: Already approved product (Tonmya, fibromyalgia) repurposed for MDD; sublingual rapid absorption; low-dose TCA profile with potentially favourable tolerability; novel sleep-mediated antidepressant hypothesis
Manufacturer #39195
Clinical and commercial-stage CNS and pain company with an FDA-approved sublingual cyclobenzaprine. Expands approved anti-fibromyalgia therapy into novel psychiatric indications via FDA IND-cleared studies. Wholly owned commercial product and pipeline with independent development.