pramocaine

Small moleculeapproved

Approved

Jun 25, 1970

Pramoxine (also known as pramocaine or pramoxine HCI) is a topical anesthetic and antipruritic. Pramoxine is used to temporarily relieve itching and pain caused by minor skin irritation such as minor burns/cuts/scrapes, sunburn, eczema, insect bites, cold sores, or rashes from poison ivy, poison oak, or poison sumac. Some products containing pramoxine are also used to temporarily relieve the itching and discomfort from hemorrhoids and certain other problems of the genital/anal area (such as anal fissures, itching around the vagina/rectum). Pramocaine is available by itself and in combination with other medications in various topical preparations. It works by preventing ionic fluctuations needed for neuron membrane depolarization and action potential propagation. Pramoxine reversibly binds and inhibits voltage gated sodium channels on neurons decreasing sodium permeability into the cell. This stabilizes the membrane and prevents ionic fluctuations needed for depolarization stopping any action potential propagation. — NCATS

Clinical trial activity

2 trials · 3 clinical orgs · 6 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Nov 1, 2013 (NCT02010099)

Timeline

1970s

Jun 25, 1970
Earliest FDA Approval
Nov 13, 1973
Ferndale Laboratories, Inc. — Marketing Organization
Aug 13, 1976
Sebela Pharmaceuticals — Marketing Organization
Aug 13, 1976
LEGACY PHARMA — Marketing Organization
Jul 26, 1978
Mylan — Marketing Organization

1980s

May 17, 1988
Genus Oncology, LLC — Marketing Organization

2010s

Jan 1, 2013
Earliest Phase 2 Sponsor(trial)

2020s

Jan 1, 2022
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Combination products

pramosone
with urea
Also known as epifoam, proctofoam hc

Approval history

approvedJun 25, 1970

Chemistry & pharmacology

Loading structure…

SMILES

CCCCOc1ccc(OCCCN2CCOCC2)cc1

Mol. weight: 293.41 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Topical
Availability: Prescription Only

Oral

Parenteral

Topical

Yes

Sources

Also known as

4-(3-(4-butoxyphenoxy)propyl)morpholine
4-(3-(p-butoxyphenoxy)propyl)morpholine
abbott brand of pramoxine hydrochloride
ascher brand of pramoxine hydrochloride
balsabit
ferndale brand of pramoxine hydrochloride
fleet brand of pramoxine hydrochloride
fleet pain relief
genderm brand of pramoxine hydrochloride
isdin brand of pramoxine hydrochloride
itch-x
medicis brand of pramoxine hydrochloride
pramegel
pramocain
pramocaine
pramocaine
pramocaine
pramocaine
pramocaine
pramocaine
pramocaine
pramocaine
pramocaine hydrochloride
pramox
pramoxin
pramoxine
pramoxine
pramoxine
pramoxine
pramoxine
pramoxine
pramoxine
pramoxine hcl
pramoxine hcl
pramoxine hcl
pramoxine hydrochloride
pramoxine hydrochloride
pramoxine hydrochloride
pramoxine hydrochloride
prax
proctofoam
ross brand of pramoxine hydrochloride
schwarz brand of pramoxine hydrochloride
seid brand of pramoxine hydrochloride
tronolane
tronolane
tronolane
tronothane
tronothane
tronothane

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05203315	Phase 3	Jan 17, 2022	Austin Institute for Clinical Research
NCT02010099	Phase 2/Phase 3 (Phase 3)	Nov 1, 2013	Maccabi Healthcare Services, Israel, Peritech Pharma Ltd.

Showing 2 of 2 trials

Page 1 / 1

Organizations

Research & Development (3)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Austin Institute for Clinical Research	For profit	1	1	1	2022
Maccabi Healthcare Services, Israel	Academic/Hospital	1	0	1	2013
Peritech Pharma Ltd.	For profit	1	1	1	2013

3 organizations

Page 1 / 1

Marketing (7)

Organization	Org type	Relationship	Date
Abbott	For profit	NDA	—
Ferndale Laboratories, Inc.	For profit	MKTG	Nov 13, 1973
Genus Oncology, LLC	For profit	MKTG	May 17, 1988
Genus Oncology, LLC	For profit	SYN	May 17, 1988
LEGACY PHARMA	For profit	MKTG	Aug 13, 1976
Mylan	For profit	MKTG	Jul 26, 1978
Sebela Pharmaceuticals	For profit	MKTG	Aug 13, 1976