Cipla’s associate company submits NDA for IV Tramadol

12 Dec 2019 Evaluate

Avenue Therapeutics, an associate company of Cipla, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

The NDA for IV tramadol is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV tramadol 50 mg dosing regimen.

In addition, the NDA includes an epidemiology study on abuse of tramadol in the US and in certain European countries where IV tramadol is available. The study finds that reports of abuse with tramadol are infrequent, both in absolute number and relative to other prescription opioids, and that abuse of tramadol via injection is uncommon relative to oral tramadol in countries where it is available.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.

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