Dosing & Uses
Dosage Forms & Strengths
Topical solution: Apply to affected area three/four times daily for 3-4 consecutive weeks and evaluate efficacy; efficacy decreased if used < 3 times daily; not to exceed 4 applications/day; wash hands with soap and water after applying
Patch: Apply patch to affected area up to 3-4 times daily for 7 days; patch may remain in place for up to 8 hr
Diabetic Neuropathy (Off-label)
Cream: Apply to affected area TID/QID times daily for 3-4 consecutive weeks and evaluate efficacy; not to exceed 4 applications/day; wash hands with soap and water after applying
Painful HIV-associated neuropathy
Treatment of intermetatarsal neuroma (Morton's Neuroma) that does not respond to conservative treatment and requires either neurectomy or neurolysis
Orphan indication sponsors
- NeurogesX, Inc; San Carlos Business Park 981F Industrial Road; San Carols, CA 94070-4117
- Vallinex Incorporated; 2400 Boston Street, Suite 330; Baltimore, MD 21224
- TheraQuest Biosciences, LLC; 146 Medinah Drive; Blue Bell, PA 19422-3212
Safety & efficacy not established
Transient increased pain at application site (dissipates w/ continued use)
Application site erythema (63%)
For external use only
Do not apply to broken skin
Do not apply to face or scalp to avoid exposure to eyes or mucous membranes
Treated area may be sensitive to heat for several days (eg, hot water, direct sunlight, vigorous exercise)
Use caution in patients with uncontrolled hypertension, history of cerebrovascular events
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Unknown whether distributed in breast milk; do not apply to nipple or areola
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Transient receptor potential vanilloid-1 (TRPV1) agonist; topical application causes initial TRPV1 stimulation that may cause pain, followed by pain relief by reduction in TRPV1-expressing nociceptive nerve endings