Biotechnology company Heron Therapeutics Inc (Nasdaq:HRTX) reported on Wednesday the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) with respect to its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
Based on its review of the HTX-011 NDA, the FDA is unable to approve the NDA in its present form due to on the need for additional CMC (Chemistry Manufacturing and Controls) and non-clinical information. The FDA did not identify any clinical safety or efficacy issues and there is no requirement for further clinical studies or data analyses.
HTX-011, which utilises the company's proprietary biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anaesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX-011 has shown to reduce pain better than placebo in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation.
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