The U.S. Food and Drug Administration has approved Vertex Pharmaceuticals’ (VRTX) non-opioid painkiller pill that has a low risk of addiction.
Vertex is the first drugmaker in decades to gain U.S. approval for a new type of pain medicine.
Past and current painkillers come with dependency risks, notably cheap and widely available opioids that have caused an epidemic of abuse and overdose deaths in the U.S.
Vertex’s drug, Journavx, is specifically approved for the treatment of moderate-to-severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures.
Around 80 million people a year are prescribed a medicine for their moderate-to-severe acute pain in the U.S.
Vertex said Journavx will have a list price of $15.50 U.S. per pill. Wall Street analysts have said that the medication could become a blockbuster drug, estimating annual sales of $1 billion U.S.
Vertex’s painkiller was more effective than a placebo at reducing the intensity of pain after 48 hours in two late-stage studies of more than 1,000 patients, said the FDA.
The most common adverse events among people who received Journavx were itching, muscle spasms and rash, added the U.S. drug regulator.
Vertex’s stock is up 8% in premarket trading on news of the painkiller’s approval. Over the last 12 months, the company’s stock has risen only 1% to trade at $438.40 U.S. per share.