Butorphanol

Overview

A synthetic morphinan analgesic with narcotic antagonist action. It is used in the management of severe pain.

Indication

For the relief of moderate to severe pain.

Associated Conditions

Pain
Perioperative Pain
Severe Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia	2024/07/29	NCT06524596	Not Applicable	Completed	Wuhan Children's Hospital
Esketamine and Butorphanol for Post-Lobectomy Pain	2024/05/03	NCT06398834	Phase 4	Completed	Second People's Hospital of Hefei City
Butorphanol in Pain Following Ablation for Hepatic Tumor	2023/09/11	NCT06031129	Not Applicable	Completed	Bibo Wang
Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation	2022/01/21	NCT05201560	Not Applicable	UNKNOWN	Shanghai Zhongshan Hospital
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation	2021/08/27	NCT05024799	Phase 4	Not yet recruiting	The Affiliated Hospital of Qingdao University
The Analgesic Effect of Butorphanol After Cesarean Section	2020/07/29	NCT04490980	Not Applicable	UNKNOWN	Tongji Hospital
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain	2020/07/20	NCT04477733	Phase 4	Completed	Beijing Tiantan Hospital
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation	2020/06/17	NCT04436224	Phase 4	UNKNOWN	Nanfang Hospital, Southern Medical University
Comparison of Analgesic Effect and Prognosis of Butorphanol and Fentanyl in Patients With Mechanical Ventilation	2020/03/20	NCT04315935	Phase 4	UNKNOWN	Jiangsu Hengrui Pharmaceutical Co., Ltd.
Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation	2019/01/18	NCT03810391	Phase 2	Completed	Shengjing Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Butorphanol Tartrate	Bryant Ranch Prepack	72162-2099	NASAL	10 mg in 1 mL	9/19/2023
Butorphanol Tartrate	Apotex Corp.	60505-0813	NASAL	10 mg in 1 mL	1/17/2024
Butorphanol Tartrate	Hikma Pharmaceuticals USA Inc.	0054-3090	NASAL	10 mg in 1 mL	9/5/2023
Butorphanol Tartrate	Hospira, Inc.	0409-1626	INTRAMUSCULAR, INTRAVENOUS	2 mg in 1 mL	2/2/2023
Butorphanol Tartrate	Hospira, Inc.	0409-1623	INTRAMUSCULAR, INTRAVENOUS	1 mg in 1 mL	2/2/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BUTORPHANOL NASAL SPRAY	aa pharma inc	02242504	Solution - Nasal	10 MG / ML	8/1/2000
PMS-BUTORPHANOL	Pharmascience Inc	02244508	Spray - Nasal	10 MG / ML	6/7/2002
STADOL NS - 10MG/ML AEM-LIQ	bristol-myers squibb canada	02113031	Liquid , Metered-Dose Aerosol - Nasal	10 MG / ML	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Trevi Therapeutics' Oral Nalbuphine Demonstrates Reduced Abuse Potential in Clinical Study

8 months ago

• Trevi Therapeutics' oral nalbuphine showed statistically significant lower "Drug Liking" compared to IV butorphanol in a human abuse potential (HAP) study. • The study assessed three doses of oral nalbuphine (81mg, 162mg, 486mg) against IV butorphanol and placebo in recreational drug users. • Secondary endpoints were consistent with the primary endpoint, with no serious adverse events reported during the study. • These results support nalbuphine's potential as a non-scheduled option for chronic cough without the abuse risks of traditional opioids.

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