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news.Johnson & Johnson Pharmaceutical Research & Development's (J&JPRD) new drug application (NDA) for Tapentadol extended release tablets has received a complete response letter (CRL) from the US Food and Drug Administration (FDA).
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Tapentadol is a centrally-acting analgesic with a dual mode of action as an agonist at the µ-opioid receptor and as a norepinephrine reuptake inhibitor.
J&JPRD’s NDA was filed to seek approval to market Tapentadol extended release as an oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.
J&JPRD said that the FDA has not requested any new clinical studies evaluating the efficacy or safety of Tapentadol extended release, but has requested for data regarding the conversion of the extended release formulation used in the clinical efficacy and safety trials to a different extended release formulation that is designed to increase mechanical resistance to breaking or crushing.
J&JPRD Therapeutic area head Analgesia Juergen Haeussler said that they would engage FDA in active discussions as quickly as possible so that they can address the requests in the Complete Response letter.