Trial Profile
Second phase I abuse liability trial of intranasally administered benzhydrocodone/paracetamol (KP 201)
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 24 Mar 2023
Price :
$35
*
At a glance
- Drugs Benzhydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
- Indications Pain
- Focus Adverse reactions
- Sponsors Zevra Therapeutics
- 22 Feb 2023 According to a KemPharm media release, KemPharm has changed its name to Zevra Therapeutics.
- 07 Jan 2019 According to a KemPharm media release, the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of APADAZ, benzhydrocodone, and acetaminophen (APAP). New dosage strengths, 4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the New Drug Application (NDA) approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of APADAZ.
- 23 Feb 2018 According to a KemPharm media release, the U.S. Food and Drug Administration (FDA) has approved New Drug Application (NDA) for Apadaz 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.