Makena: New Randomized Trial May Only Happen If Drug Stays On The US Market

 
• By Sue Sutter

Covis declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.

Makena mist
Covis declined to offer a clear view on whether it would do another trial in Makena were removed from the market. • Source: Shutterstock

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