The drug major plans to submit a supplemental new drug application for Solosec to the US drug regulator forthe treatment of trichomoniasis in H2 2020.
Pharmaceutical major Lupin on Monday, 4 May announced its US-based wholly owned subsidiary, Lupin Pharmaceuticals Inc. reported positive top-line results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec (secnidazole) 2g oral granules in 147 female patients with trichomoniasis.Trichomoniasis is the most common non-viral, curable, sexually transmitted infection (STI) in the US. It is caused by a protozoan parasite called Trichomonas vaginalis. The trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec as compared to placebo (p<0.001).
The company said it plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (U.S. FDA) for Solosec for the treatment of trichomoniasis in the second half of 2020.
Commenting on the positive results, Gregory Kaufman, M.D. Senior Vice President, Global Clinical and Medical Affairs, Lupin said, Trichomoniasis impacts an estimated 3 to 5 million people in the U.S. We are encouraged by the topline results of our clinical trial, look forward to finalizing the analysis, and working with the FDA to provide a new single-dose therapy option to physicians and patients, to treat this disease.
Lupin was up 2.57% to Rs 862.70 on BSE. The stock has jumped 31.7% in last one month from its previous closing low of Rs 654.80 posted on 3 April 2020.
Lupin is engaged in producing, developing and marketing a range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) across the world
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