FDA Approves Apadaz sNDA for 2 New Strengths

The US Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for 2 new doses of Apadaz, a combination of benzhydrocodone, and acetaminophen (Apap). The newly approved combinations consist of 4.08 mg benzhydrocodone/325 mg acetaminophen and 8.16 mg benzhydrocodone/325 mg acetaminophen.

The pain medication is intended for the short-term management of acute pain severe enough to require an opioid analgesic, to be used for no more than 14 days. Due to the risk addiction or abuse of opioids, Apadaz is recommended only for use in patients for whom opioid alternatives are not tolerated or adequate.

“When commercializing a new product in a very large market, such as with Apadaz, minimizing potential barriers for both physicians and health plans is paramount to facilitating the potential replacement of other hydrocodone/Apap products currently available. We believe the timing of this sNDA approval is great news for a second half 2019 launch with our commercial partner, KVK-Tech,” said Travis Mickle, PhD, KemPharm’s President and Chief Executive Officer. “We believe the sNDA approval of the 2 additional strengths of Apadaz enhances the marketability, and ultimately the acceptance of the product, by offering physicians maximum flexibility when prescribing the product.”

Apadaz is contraindicated for patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment, known or suspected gastrointestinal obstruction, and hypersensitivity to hydrocodone or acetaminophen.

The most commonly reported adverse reactions (>5%), according to the Apadaz Prescribing Information, include nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.

This sNDA follows the FDA’s approval of the Apadaz NDA in February 2018 for the short-term management of acute pain. The original dosage of Apadaz was 6.12 mg benzhydrocodone/325 mg acetaminophen.