Torrent Pharma Tapentadol Nasal Spray gets CDSCO panel go ahead for phase 3 trial

New Delhi: The Ahmedabad-based pharmaceutical major, Torrent Pharma, has received permission from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase III Clinical Trial of Tapentadol Nasal Spray 225mg/ml, which is used to relieve moderate to severe short-term pain.

However, the SEC approval came with conditions, wherein the expert panel directed the firm that a waiting period of 60 minutes for administering the rescue medication is not acceptable and it should be reduced to 30 minutes. In addition, the committee also instructed the firm to include the standard of care in an amended version of the protocol that would be delivered to all patients in three sub-groups.

This recommendation came after the drug-maker presented the revised Phase III clinical trial (CT) protocol for Tapentadol Nasal Spray 225mg/ml before the Committee at a recent SEC meeting for analgesics and rheumatology.

Tapentadol is a centrally acting analgesic having both m-opioid receptor agonist and noradrenalin (norepinephrine) reuptake inhibition activity with minimal serotonin reuptake inhibition. This dual mode of action makes tapentadol particularly useful in the treatment of both nociceptive pain and neuropathic pain.

Tapentadol is available commercially under the brand name NUCYNTA as 50mg, 75mg, and 100 mg oral tablets, indicated for the relief of moderate to severe acute pain.

The Medical Dialogues Team had reported earlier that following the Torrent Pharma's proposal for manufacturing and marketing of Tapentadol Nasal Spray 225mg/ml, the CDSCO Committee, at its 72nd SEC meeting for Analgesics & Rheumatology held on 24.06.2021 & 25.06.2021, had recommended the firm to revise the Phase III CT protocol according to the following conditions:

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 the test products are opioids (Tapentadol & Tramadol).

Accordingly, at the 74th SEC meeting for Analgesics & Rheumatology, in light of earlier SEC recommendations dated 24.06.2021 & 25.06.2021, the firm presented the revised Phase III CT protocol for Tapentadol Nasal Spray 225mg/ml before the Committee.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III Clinical Trial as per protocol presented subject to the following conditions.

1. The waiting period of 60 min for administering the rescue medication is not acceptable and should be reduced to 30 min.

2. Standard of care should be mentioned in the amended version of the protocol to be given to all patients in three sub-groups.