KemPharm announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for 2 new strengths of Apadaz (benzhydrocodone, acetaminophen): 4.08mg/325mg and 8.16mg/325mg. 

Apadaz was initially approved in February 2018 as 6.12mg/325mg immediate-release tablets for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The product combines benzhydrocodone, an opioid agonist, and acetaminophen. Benzhydrocodone is chemically inert, however, once ingested, enzymes in the gastrointestinal tract cleave the ligand from the prodrug and release hydrocodone, producing a therapeutic effect. Approval was based on pharmacokinetic studies which showed that the therapeutic effects of Apadaz were expected to be similar to that of other immediate-release hydrocodone/acetaminophen combination products

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Travis Mickle, PhD, KemPharm’s President and Chief Executive Officer, stated, “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.”

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