Cipla rises after associate firm submits NDA to USFDA for IV tramadol

Cipla advanced 1.77% to Rs 457.65 after associate firm, Avenue Therapeutics, announced submission of new drug application to the US drug regulator for intravenous tramadol.

Cipla's associate company, Avenue Therapeutics, which majorly focuses on the development of intravenous (IV) tramadol for the U.S. market, announced that it submitted a new drug application (NDA) to the United States 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.

IV tramadol is a potential alternative that could reduce the use of conventional opioids for patients suffering from acute pain.

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 U.S. 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. The announcement was made after trading hours yesterday, 11 December 2019.

Meanwhile, the S&P BSE Sensex was up 128 points or 0.32% to 40,540.45.

In the past one month, shares of Cipla rose 2.09% to its current market price of Rs 457.65, underperforming the Nifty Pharma index's 4.85% gain in the same period.

On the technical front, the stock's RSI (relative strength index) stood at 46.584. The RSI oscillates between zero and 100. Traditionally the RSI is considered overbought when above 70 and oversold when below 30.

The stock was currently trading above its 50-day moving average (DMA) placed at Rs 455.62, but still below its 200 DMA placed at Rs 510.37.

On a consolidated basis, net profit of Cipla rose 25% to Rs 471.35 crore on 8% rise in net sales to Rs 4,264.24 crore in Q2 September 2019 over Q2 September 2018.

Cipla is a global pharmaceutical company focused on complex generics, and deepening of portfolio in markets of India, South Africa, North America, and key regulated and emerging markets. The company's strengths lay in the respiratory, anti-retroviral, urology, cardiology, anti-infective and central nervous system (CNS) segments.

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