Overview
Scopolamine is a tropane alkaloid isolated from members of the Solanaceae family of plants, similar to atropine and hyoscyamine, all of which structurally mimic the natural neurotransmitter acetylcholine. Scopolamine was first synthesized in 1959, but to date, synthesis remains less efficient than extracting scopolamine from plants. As an acetylcholine analogue, scopolamine can antagonize muscarinic acetylcholine receptors (mAChRs) in the central nervous system and throughout the body, inducing several therapeutic and adverse effects related to alteration of parasympathetic nervous system and cholinergic signalling. Due to its dose-dependent adverse effects, scopolamine was the first drug to be offered commercially as a transdermal delivery system, Scopoderm TTS®, in 1981. As a result of its anticholinergic effects, scopolamine is being investigated for diverse therapeutic applications; currently, it is approved for the prevention of nausea and vomiting associated with motion sickness and surgical procedures. Scopolamine was first approved by the FDA on December 31, 1979, and is currently available as both oral tablets and a transdermal delivery system.
Indication
Scopolamine is indicated in adult patients for the prevention of nausea and vomiting associated with motion sickness and for the prevention of postoperative nausea and vomiting (PONV) associated with anesthesia or opiate analgesia.
Associated Conditions
- Motion Sickness
- Post Operative Nausea and Vomiting (PONV)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/03 | Phase 4 | Not yet recruiting | |||
2024/01/17 | Early Phase 1 | Completed | |||
2023/08/28 | Phase 1 | Withdrawn | |||
2022/10/26 | Early Phase 1 | Recruiting | |||
2021/08/10 | Phase 1 | Recruiting | |||
2021/04/29 | Not Applicable | Completed | University of Alcala | ||
2021/03/05 | Phase 4 | Completed | |||
2020/12/24 | Phase 4 | Completed | |||
2020/12/14 | Phase 2 | Withdrawn | EMS | ||
2020/08/07 | Phase 1 | Completed | Nobelpharma |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ATLANTIC BIOLOGICALS CORP. | 17856-0162 | ORAL | .0065 mg in 5 mL | 6/15/2018 | |
| Winder Laboratories, LLC | 75826-118 | ORAL | 0.0065 mg in 1 1 | 12/27/2019 | |
| Ingenus Pharmaceuticals, LLC | 50742-667 | ORAL | 0.0065 mg in 1 1 | 1/10/2023 | |
| PBM Pharmaceuticals Inc. | 66213-422 | ORAL | 0.0065 mg in 5 mL | 12/3/2013 | |
| Concordia Pharmaceuticals Inc. | 59212-425 | ORAL | 0.0065 mg in 1 1 | 1/10/2023 | |
| TPS | 69267-201 | ORAL | .25 mg in 20.25 mg | 10/15/2014 | |
| Ingenus Pharmaceuticals, LLC | 50742-505 | TRANSDERMAL | 1.5 mg in 1 1 | 3/9/2022 | |
| Physicians Total Care, Inc. | 54868-2803 | TRANSDERMAL | 1 mg in 3 d | 3/26/2013 | |
| Bryant Ranch Prepack | 72162-1419 | TRANSDERMAL | 1 mg in 1 1 | 12/5/2023 | |
| PBM Pharmaceuticals Inc. | 66213-423 | ORAL | 0.0065 mg in 5 mL | 12/3/2013 |
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 |
|---|---|---|---|---|---|
| FUCON CAPSULE 10 mg | SIN07177P | CAPSULE | 10 mg | 10/9/1992 | |
| HYOMIDE TABLET 10 mg | SIN02854P | TABLET, SUGAR COATED | 10 mg | 5/24/1989 | |
| FUCON INJECTION 20 mg/ml | SIN07796P | INJECTION | 20 mg/ml | 7/15/1994 | |
| YSP HYOSCINE INJECTION 20MG/ML | SIN16636P | INJECTION, SOLUTION | 20mg/ml | 11/7/2022 | |
| VACOPAN INJECTION 20 mg/ml | ATLANTIC LABORATORIES CORPN LTD | SIN09563P | INJECTION | 20 mg/ml | 11/25/1997 |
| HYOSUN SYRUP 5mg/5 ml | SIN07433P | SYRUP | 5 mg/5 ml | 5/20/1993 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Scopolamine Hydrobromide Adhesive Patches | 国药准字H10880042 | 化学药品 | 贴剂 | 6/29/2020 | |
| Methscopolamine Bromide Tablets | 国药准字H44025123 | 化学药品 | 片剂 | 4/7/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AIRMIT TAB (TAIWAN) | N/A | N/A | N/A | 1/14/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PHARMACY HEALTH TRAVEL SICKNESS TABLETS strip pack | 335591 | Medicine | A | 5/1/2020 | |
| AMCAL TRAVEL SICKNESS TABLETS strip pack | 345907 | Medicine | A | 10/14/2020 | |
| TRAVACALM ORIGINAL tablet strip pack | 14864 | Medicine | A | 9/5/1991 | |
| ADIRAMEDICA TRAVEL SICKNESS TABLETS strip pack | 335590 | Medicine | A | 5/1/2020 | |
| Scopoderm | 233258 | Medicine | A | 1/30/2015 | |
| TRAVELMED tablet blister pack | 490795 | Medicine | A | 6/4/2025 | |
| TRAVACALM ORIGINAL tablet blister pack | 78192 | Medicine | A | 4/18/2001 | |
| APOHEALTH TRAVEL SICKNESS TABLETS strip pack | 355903 | Medicine | A | 3/1/2021 | |
| DONNATAB tablet blister pack | 60604 | Medicine | A | 7/8/1997 | |
| BLOOMS THE CHEMIST TRAVEL SICKNESS TABLETS strip pack | 372732 | Medicine | A | 8/12/2021 |
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