(Reuters) -Viatris’ fast-acting form of generic pain drug meloxicam met the main goals of two late-stage studies, the company said on Thursday, adding that it would seek the US FDA’s marketing approval for the drug by the end of the year.
The company’s shares were up 1.6% in premarket trading.
The drug was tested in one of the studies in patients who had surgery for the repair of hernia, while in the other, in those who had undergone a surgical procedure to correct bunions, a deformity at the big toe joint.
In both the studies, the drug led to improvement in pain compared to placebo, as measured by a commonly used scale to evaluate the effectiveness of pain treatments, called Sum of Pain Intensity Difference.
It also helped reduce usage of opioids, which are highly addictive, over the entire treatment phase.
“The data observed in two surgical models… is a critical step in the development of a safe and effective non-opioid option to address an important public health need,” said Philippe Martin, Viatris’ research and development chief.
Separately, the company also said that a lower dose version of its birth control patch, called Xulane, also met all the main goals of a late-stage study.
Viatris plans to seek the FDA’s approval for the patch, branded Xulane Lo, in the second half of the year.
(Reporting by Puyaan Singh in Bengaluru; Editing by Shailesh Kuber)
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