Present More Data on drug abuse potential of Tapentadol: CDSCO tells Wockhardt for FDC Dicyclomine,Tapentadol
New Delhi: Regarding the fixed dose combination (FDC) drug Dicyclomine plus Tapentadol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug maker Wockhardt to submit more data on the drug abuse potential of Tapentadol.
In addition, the committee recommended the firm to submit a revised clinical trial (CT) protocol of the FDC drug by incorporating the mechanism to evaluate the drug abuse potential of Tapentadol.
This recommendation came after the proposal was decided for re-deliberation before the Committee with respect to 1430 incidents reported for involving the seizure of Tapentadol.
Earlier, at 53rd SEC meeting for Gastroenterology & Hepatology held on 18.10.2022, in response to drug maker Wockhardt's revised Phase III CT protocol, the expert panel recommended for conducting the Phase III CT study.
Dicyclomine is an antimuscarinic agent used to treat Irritable bowel syndrome (IBS). Dicyclomine achieves its action partially through direct antimuscarinic activity of the M1, M3, and M2 receptors; and partially through antagonism of bradykinin and histamine. Dicyclomine non-competitively inhibits the action of bradykinin and histamine, resulting in direct action on the smooth muscle, and decreased strength of contractions seen in spasms of the ileum.
Tapentadol is an opioid used to manage severe pain that has not responded to non-opioid medications, and for which opioid analgesic therapy is appropriate. Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
At the recent SEC meeting for Gastroenterology &Hepatology held on 22.02.2023, the expert panel reviewed the proposal which was decided for re-deliberation before the Committee with respect to 1430 incidents reported for involving the seizure of Tapentadol.
2. Firm should present a revised CT protocol by incorporating the mechanism to evaluate the drug abuse potential of Tapentadol.
Accordingly, the expert panel suggested the firm to present the proposal before SEC.
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