rizatriptan/naproxen / Eurofarma - LARVOL DELTA

Submit Rationality And Desirability Of Rizatriptan Plus Naproxen: CDSCO Panel Tells Akum Drugs And Pharmaceutical (Medical Dialogues) - "Noting that the firm did not present adequate justification/rationale for the proposed fixed-dose combination (FDC) of rizatriptan benzoate plus naproxen sodium USP (5mg + 550mg and 10mg + 550mg) filmcoated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined to the drug maker Akums Drugs and Pharmaceuticals that more published scientific literature in peer-reviewed journals in support of the rationality and desirability of the proposed FDC should be submitted...This came after Akums Drugs and Pharmaceuticals presented the proposal along with the BE (bioequivalence) study protocol and Phase III clinical trial protocol before the committee....At the recent SEC meeting for neurology and psychiatry held on 19th March 2025, the expert panel reviewed the proposal along with the BE study protocol and Phase III clinical trial protocol."

Clinical protocol • Migraine

Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine (clinicaltrials.gov) - P3 | N=2068 | Completed | Sponsor: Eurofarma Laboratorios S.A. | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Nov 2024 | Trial primary completion date: Jan 2025 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine (clinicaltrials.gov) - P3 | N=2068 | Recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: May 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine (clinicaltrials.gov) - P3 | N=1664 | Recruiting | Sponsor: Eurofarma Laboratorios S.A. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Sep 2024 ➔ May 2024

Enrollment open • Trial primary completion date • CNS Disorders • Migraine

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine (clinicaltrials.gov) - P3 | N=1664 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Apr 2024 ➔ Mar 2025 | Trial primary completion date: Jan 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • CNS Disorders • Migraine

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine (clinicaltrials.gov) - P3 | N=1664 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Oct 2022 ➔ Apr 2024 | Trial primary completion date: Jul 2022 ➔ Jan 2024

Trial completion date • Trial primary completion date • CNS Disorders • Migraine

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine (clinicaltrials.gov) - P3; N=1524; Not yet recruiting; Sponsor: Eurofarma Laboratorios S.A.

Clinical • New P3 trial • CNS Disorders • Migraine