Pain Rx Gets Green Light

The US Food and Drug Administration (FDA) has approved a new drug to treat short-term severe pain.

This new approval is for Apadaz. It's an opioid analgesic (narcotic pain reliever) that contains two medications: benzhydrocodone and acetaminophen.

Benzhydrocodone is a prodrug of the active opioid drug hydrocodone. Prodrugs are not active on their own — they must be swallowed and then activated inside the body in order to work. Once benzhydrocodone (the prodrug) is activated in the stomach and intestines, hydrocodone (the active drug) relieves pain by changing the way the brain and nervous system respond to pain. Acetaminophen helps to relieve pain by changing the way the body senses pain.

Apadaz is the first prodrug of hydrocodone and acetaminophen to be approved by the FDA. Apadaz is only indicated for short-term pain that is severe enough to require an opioid — and only if the pain does not respond to other pain medications. This medication is not to be used for more than 14 days.

Do not take Apadaz with alcohol or with products that contain acetaminophen. This medication can interact with many medications, which can be dangerous. Tell your health care provider about all the medicines you take, including prescription and non-prescription medications, vitamins and herbal supplements.

This medication may not be safe for some people. That includes women who are pregnant or breastfeeding and those with significant respiratory depression, acute or severe asthma, known or suggested obstruction (blockage) of the stomach, or an allergy to benzhydrocodone or acetaminophen.

Side effects of Apadaz include nausea, tiredness, vomiting, constipation, itching, dizziness and headache. Because Apadaz is an opioid, it poses the risks of addiction, abuse and misuse. These risks can lead to overdose and death. If you have a personal or family history of addiction, tell your health care provider.

The FDA granted the approval of Apadaz to KemPharm, Inc.

Written By Anyssa Garza, PharmD, BCMAS