Revise phase 3 clinical trial protocol for Tapentadol Nasal Spray: CDSCO panel tells Torrent Pharma

Medical Dialogues Team had reported earlier that the National Pharmaceutical Pricing Authority (NPPA) had granted a rare exemption from the price cap to Torrent Pharmaceuticals' Tapentadol Nasal Spray for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.

The CDSCO Committee thoroughly examined the proposal presented by Torrent Pharmaceuticals at its 72nd SEC meeting for Analgesic & Rheumatology held on 24.06.2021 & 25.06.2021 at CDSCO.

Responding to the proposal, after detailed deliberation, the committee recommended revising the Phase III CT protocol as follows: 

1. The subject population included patients from 3 different clinical indications. All these sub-group patients should be clearly defined in terms of clinical presentation/pain scores.

2. Sample size should be recalculated based on statistical calculation & justifiable in these 3 sub-groups.

3. Study design should be modified & it should preferably be blinded.                                                                                                                                               

4. The rescue medications should be changed as test products are opioids (Tapentadol & Tramadol)

In addition to this, the committee also directed that the firm should submit a revised Phase III Clinical Trial protocol before the Committee.