Remoxy is a capsule formulation of oxycodone intended to prevent opioid abuse.
In a letter to the company, the FDA said the data gathered from test trials of Remoxy showed there are more associated risks than benefits.
“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” Remi Barbier, CEO of Pain Therapeutics, said in a press release.
Following the drug’s rejection, Pain Therapeutics launched a strategic realignment, which will involve shifting the company’s focus to developing treatments and diagnostic products for Alzheimer’s disease.
“They are kind of backed into a corner when their drug gets rejected and there does not seem to be a path forward,” Kevin Kedra, an analyst at Gabelli & Co., which owns about 1 percent of the drugmaker’s shares, told Reuters. “That’s what companies have to do to stay alive I guess.”
Pain Therapeutics’ stock dropped 35.3 percent to $1.56 per share on August 6 after Remoxy’s rejection. Overall, shares have fallen 40 percent in 2018.
More articles on opioids:
FDA knew about dangerous opioid misuse, but failed to intervene, documents show
Children in these 3 states experience opioid-related parent loss, incarceration above the national average
Opioid prescriptions static since 2007 despite increased awareness of misuse
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
