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Orexo gets FDA approval for opioid addiction-fighting Zubsolv

Approval comes weeks after FDA rejects Titan Pharmaceuticals' Probuphine
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The FDA is wrestling with a host of issues surrounding highly addictive and often abused opioids and just recommended a drug that may provide some help in its effort.

Swedish drug developer Orexo said Thursday that the FDA had approved its Zubsolv to treat opioid addiction, a problem that the company says affects nearly 5 million people in the U.S. and leads to about 17,000 deaths annually. Only about 20% of people addicted to the painkillers get any treatment, the company said. "We anticipate a peak market potential of at least $500M," Orexo CEO Nikolaj Sørensen said in a statement.

As Reuters points out, Zubsolv combines the drugs buprenorphine and naloxone and will compete with similar products Subutex and Suboxone, made by Britain's Reckitt-Benckiser.

In May, the FDA rejected the recommendation from its panel of outside experts and decided against approval of Titan Pharmaceuticals' ($TTNP) Probuphine for treating opioid addiction. The agency raised a host of issues about Titan's drug.

Doctors rely heavily on opioids for pain control, but because they are so often abused, the FDA has been under mounting pressure to limit their use. The FDA held hearings in February as it continues to walk a very fine line between the dangers of addiction and the need for flexibility in how doctors treat patients with chronic pain. It heard strong support from both sides. Some members in Congress are pushing for legislation to limit their use.

- here's the release
- more from Reuters

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Titan's Probuphine could help FDA in its efforts to fight opioid abuse
FDA hearing on opioids reflects evolving view on painkiller use