vSoothe 1 Vaginal Cream

Amitriptyline HCL / Baclofen / Gabapentin Cream is a topical or intravaginal therapy used to treat symptoms related to vulvodynia and Provoked Vestibulodynia. These conditions cause vulvar discomfort, usually burning pain, and dyspareunia, in the absence of any specific cause.1 Vestibulodynia can have a profound effect on women’s sexuality and psychological well-being.2

Amitriptyline

Amitriptyline is a tertiary amine tricyclic antidepressant (TCA) that is metabolized to an active metabolite, nortriptyline. Tertiary amines are generally more sedating and have greater anticholinergic effects than secondary amines. Amitriptyline is also related to the skeletal muscle relaxant cyclobenzaprine, although amitriptyline is not believed to possess muscle-relaxant properties. Amitriptyline is FDA-approved for the treatment of adults with major depressive disorder (MDD). Clinically, amitriptyline is also used to treat neuropathic pain and other conditions.

Baclofen

Baclofen is an oral skeletal muscle relaxant. It is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Clinically, baclofen is used to treat spasticity and improve mobility in patients with multiple sclerosis and other spinal cord lesions by decreasing the number and severity of spasms and relieving associated pain, clonus, and muscle rigidity.

Gabapentin

Gabapentin is an analog of gamma-aminobutyric acid (GABA) that has GABA agonist activity. Its unique pharmacokinetic properties make it especially useful in certain patients. Gabapentin possesses high lipid solubility, is not metabolized by the liver, has no protein binding, and is devoid of enzyme induction-related drug interactions. Originally developed as an anticonvulsant, gabapentin has been shown to be effective as adjunct therapy in the treatment of partial seizures with or without secondary generalized tonic-clonic seizures. Efficacy in the treatment of painful neuropathies has also been demonstrated. Investigational uses include monotherapy of refractory partial seizure disorders, treatment of spasticity in multiple sclerosis, and tremor. In addition, gabapentin appears to be effective in reducing hot flashes in menopausal women or women with breast cancer.3

Topical gabapentin in the treatment of localized and generalized vulvodynia4

Participants: 150 patients presenting with entry dyspareunia
Administration: Topical (local)
Dosage: 2% Cream
Conclusion: 80% of respondents demonstrated at least a 50% improvement in pain scores. Topical gabapentin seems to be well-tolerated and associated with significant pain relief in women with vulvodynia.

Use of amitriptyline cream in the management of entry dyspareunia due to provoked vestibulodynia5

Participants: 35 women
Administration: Topical (local)
Dosage: 2% Cream
Conclusion: Topical amitriptyline cream should be considered for first-line treatment in the management of patients with provoked vestibulodynia causing entry dyspareunia. The response rate is reasonable (56%), and it eliminates the problems with systemic administration, namely, drowsiness and the difficulty patients have in accepting antidepressant medication for their condition.

Topical Amitriptyline-Baclofen Cream for the Treatment of Provoked Vestibulodynia2

Participants: 38 women
Administration: Topical (local)
Dosage: 2% Baclofen & 2% Amitriptyline Cream
Conclusion: 71% response rate in women with refractory symptoms and the overall tolerability of treatment.