(Reuters) - Zogenix Inc said the U.S. Food and Drug Administration approved its drug for treating pain severe enough to require around-the-clock, long-term treatment, sending the specialty pharmaceutical company’s shares up as much as 54 percent.
The drug is approved for use in patients for whom alternate treatment has proved inadequate or ineffective.
The FDA requires post-marketing studies for the drug, Zohydro ER, to assess the known risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks.
Zohydro ER is an extended release formulation of a common painkiller hydrocodone, which belongs to a widely-used class of pain drugs known as opioids. (link.reuters.com/tes24v)
Given the huge number of cases of abuse seen with opioids, Zohydro ER is not approved for as-needed pain relief.
Abuse of prescription drugs has become a major concern for the U.S. health regulator, which is trying to restrict access to such drugs.
The agency recommended on Thursday tighter restrictions on products that contain hydrocodone, present in commonly prescribed, potentially addictive drugs such as Vicodin.
The most common side effects of Zohydro ER include constipation, nausea, fatigue, headache, dry mouth and itching, the FDA said in a statement on its website on Friday.
Zogenix shares were up 40 percent at $3.14 in Friday afternoon trading on the Nasdaq.
Reporting by Natalie Grover in Bangalore; Editing by Kirti Pandey