The FDA has given the green light to a new pain medication developed by KemPharm.
According to the company, the treatment, called Apadaz, is designed for short-term management of acute pain. Apadaz combines 325 mg of acetaminophen with 6.67 mg of benzhydrocodone (a prodrug of hydrocodone).
The agency had previously rejected the drug in September 2016 over concerns of abuse.
Even though it has now been approved, KemPharm reported that it will be classified as a Schedule II controlled substance, signaling that it has a high potential for abuse.
KemPharm says that what sets the new treatment apart from other medications is that when ingested, “enzymes in the gastrointestinal tract cleave the ligand from the prodrug (benzhydrocodone) and release the parent drug (hydrocodone), which can then exert its therapeutic effect.”
KemPharm expects to produce about 5 billion tablets of Apadaz a year and said that it is hoping to establish a partnership with a generics maker or a non-traditional pact with a pharmacy benefit manager.