FDA Approves Short-Term Acute Pain Management Drug

FEBRUARY 24, 2018
Officials with the FDA have approved benzyhydrocodone and acetaminophen (Apadaz, KemPharm) for short-term acute pain management, according to a press release from the manufacturer. 

The alternative pain management therapy can be prescribed when pain is severe enough to require an opioid analgesic, according to the release.

“The approval of Apadaz is a significant milestone for KemPharm as it creates the opportunity to introduce what we believe is a differentiated product for the short-term management of acute pain,” Travis Mickle, PhD, president, KemPharm said in a press release.  “Based on its unique properties, we firmly believe there is a commercial pathway for Apadaz in what is a very high-volume market.  We are excited by the opportunity Apadaz offers to patients and for physicians who now have the option of prescribing a differentiated product.”

KemPharm developed the novel drug using their patented ligand active therapy (LAT) platform technology.  Apadaz is chemically inactive until ingested, unlike other opioids alternatives, according to the release. The inert prodrug reacts with enzymes in the gastrointestinal tract to separate the ligand and release hydrocodone, which causes the therapeutic effect.

Apadaz is indicated for acute, severe pain when other opioid alternatives are insufficient; however, the treatment should not be taken for more than 14 days, according to the release.

Patients who are exposed to opioids, including Apadaz, are at a heightened risk of addiction, abuse, and misuse. To prevent addiction, KemPharma officials recommend reserving Apadaz for patients only when an alternative treatment cannot be tolerated or does not produce adequate effects.

Apadaz is not recommended for patients with respiratory depression, acute bronchial asthma who do not have access to resuscitative equipment, gastrointestinal obstruction, and hypersensitivity to hydrocodone and acetaminophen, according to the press release.

Patients with chronic pulmonary diseases and patients weakened by age or debilitating conditions are at risk for developing life-threatening respiratory depression. Patients with increased intracranial pressure, brain tumors, head injuries, impaired consciousness, and gastrointestinal conditions are also at risk of adverse effects from Apadaz, according to KemPharma.

Other risks include neonatal opioid withdrawal syndrome, adrenal insufficiency, hypotension, skin reactions, hypersensitivity or anaphylaxis, withdrawal, and risks operating machinery, according to the release.

Apadaz can interact with serotonergic drugs, mixed agonist/antagonist, partial agonist opioid analgesics, and monoamine oxidase inhibitors. Concomitant use with benzodiazepines and cytochrome P450 CYP3A4 inhibitors can also have negative effects, such as acetaminophen hepatoxicity, and is not recommended.

The most common side effects associated with Adapaz are nausea, somnolence, constipation, pruritus, dizziness, and headache, according to the release.

KemPharm plans to move forward in using the same LAT technology used to create Apadaz in the development of new drugs.

“Finally, today is a validation of KemPharm’s groundbreaking LAT platform and our technological approach to drug development,” Dr Mickle said in the release.  “KemPharm is first and foremost a prodrug development company.  The Apadaz approval highlights the value potential that LAT offers in the discovery and development of proprietary prodrugs that are designed to be differentiated versions of widely prescribed, currently approved drugs, and that can successfully complete the rigorous regulatory process.”

Reference
KemPharm Announces FDA Approval of Apadaz™ (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain [news release]. Coralville, Iowa. KemPharma website. . Accessed February 23, 2018.
 

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