Benzhydrocodone/Acetaminophen Combination Gets FDA Approval for Severe Acute Pain

July 31, 2018 by Dr. Clemens Leave a Comment

The Food and Drug Administration (FDA) has approved Apadaz (benzhydrocodone and acetaminophen; KemPharm) for the short-term (≤14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Apadaz is an immediate-release combination of benzhydrocodone, a prodrug of hydrocodone, and acetaminophen (APAP).

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.

“In addition to today’s approval, the US Drug Enforcement Administration (DEA) has indicated that it is their intent to schedule Apadaz as a C-II product and will provide an allocation of the Active Pharmaceutical Ingredient (API) consistent with those scheduling provisions,” said Travis Mickle, PhD, KemPharm President and Chief Executive Officer.

“This prompt decision by the DEA essentially completes the regulatory process with both Agencies and allows us to shift our focus towards the product launch.”

Apadaz will be supplied as a 6.12 mg/325 mg tablet.

Leave a Reply Cancel reply

You must be logged in to post a comment.

Call (660) 596-2224

What people thought about us

“As Director of Surgical Services Departments there has been considerable changes have occurred in my department and Anesthesia Experts has always risen to meet our demands of our facility. They have been very pro-active in meeting the increase volumes allowing us to keep our surgeons and patients very satisfied with our services.”

AR BSN 346 beds AL

“Before AE took over the anesthesia department was described by the surgeons as the worst in the history of our hospital. The prior management company was having a cancelled surgery per day. I am happy to report there has not been one since they have taken over the department. Additionally we have seen a 905 reduction if requested preop
lab tests. The anesthesia department is now the very best hospital department in our entire facility.”

DS CEO 272 beds MS

“Anesthesia Experts has provided consistent anesthesia providers who display a high degree of integrity, responsibility and professionalism. They have become a more valuable part of our facility and community.”

LR CEO 150 beds TX

“Even though they are physically located 1000 miles away Anesthesia Experts just does not provide great anesthesia coverage they personally engage surgeons to increase their business. Last year my surgical volume rose by 24% and we are currently 50% ahead of last year and all of that growth is organic.”

JE FACHE CEO AL 92 bed hospital

“Anesthesia Experts is more responsive than anyone I have dealt with. They are available by phone whenever needed and will be on site for any need or request and has been on site to address issues before we can make the request.”

SW CEO 25 beds NM

“While problems are extremely rare when they do occur Anesthesia Experts quickly and professionally implements a solution. Our surgical volume has grown over 100 cases per month and now our GI docs want to perform all of their endoscopies in our hospital instead of their GI lab that they own!”

SP CEO 346 beds AL

“Our anesthesia department was a thorn in my side that kept me awake at night. Anesthesia Experts swept in and brought order to our mess and our department was quickly redirected.”

JAM CNO AL 89 bed hospital