NUCYNTA

LOE Approaching

tapentadol hydrochloride

NDAORALTABLET
Approved
Nov 2008
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
3

Mechanism of Action

centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from…

Indications (3)

acute pain severe enough to require an opioid analgesicfor which alternative treatments are inadequate in adultsolder with a body weight of at least 40 kg

Clinical Trials (3)

NCT01719601N/AWithdrawn

A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain

Started Oct 2014
0
Moderate to Severe Acute Non-Cancer Pain
NCT01719588N/AWithdrawn

A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain

Started Oct 2014
0
Moderate to Severe Chronic Non-cancer Pain
NCT00986180Phase 3Completed

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

Started Sep 2009
667 enrolled
PainBack PainLow Back Pain+1 more

Loss of Exclusivity

LOE Date
Jul 3, 2026
4 months away
Exclusivity Expiry
Jan 3, 2027
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers