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1 products found

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.
 

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