[Pharmacologic properties and results of a clinical study of oxybutynin hydrochloride lotion (APOHIDE Lotion 20%) as a novel treatment for primary palmar hyperhidrosis].

APOHIDE Lotion 20% is a topical agent for treating primary palmar hyperhidrosis that contains the active ingredient oxybutynin hydrochloride. Oxybutynin hydrochloride has anticholinergic effects and inhibits sweating by binding to the M receptor, a subtype of the muscarinic acetylcholine receptor, in eccrine sweat glands. The clinical response to oxybutynin hydrochloride treatment also involves N-desethyloxybutynin, an active metabolite of oxybutynin.

Combined Efficacy of Systemically Acting Diclofenac Sodium Patch and Alpha-2-Delta Calcium Channel Ligand in Chronic Low Back Pain: Subanalysis of a Phase III Study.

Introduction: Chronic low back pain often comprises mixed pain types and involves multiple factors. Therefore, we hypothesized that the systemic transdermal formulation of diclofenac sodium (DF systemic patch), which is effective for nociceptive pain, and an α2δ Ca channel ligand, which is effective for neuropathic pain, would have additive effects in the treatment of chronic low back pain.

Methods: From among participants in a randomized, double-blind, placebo-controlled study of DF systemic patch (75 or 150 mg) applied once daily for 2 weeks in patients with chronic low back pain, we performed a subpopulation analysis of those who were concomitantly treated with an α2δ Ca channel ligand during the study period.

Long-term evaluation of the safety and efficacy of a novel 20% oxybutynin hydrochloride lotion for primary palmar hyperhidrosis: An open-label extension study.

The long-term safety and efficacy of 52-week application of oxybutynin hydrochloride 20% lotion (20% OL) for the treatment of primary palmar hyperhidrosis (PPHH) in Japanese patients aged ≥12 years were evaluated in an open-label extension (OLE) of a 4-week, randomized, double-blind (DB) study. The OLE included 114 patients who completed the DB study and wished to continue treatment and 12 new patients. In the safety analysis population (125 patients), the incidence of adverse events (AEs) and adverse drug reactions (ADRs) was 79.

A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study.

Background: No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.

Objective: To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).

Methods: In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks.

Systemically Acting Diclofenac Sodium Patch for Control of Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Study in Japan.

Introduction: Nonsteroidal antiinflammatory drugs (NSAIDs) are commonly used for pain disorders such as low back pain and exist in multiple formulations; however, no systemically acting transdermal formulations are available for low back pain. Transdermal formulations can be safely administered even to patients with trouble swallowing or at risk of aspiration, and without regard to the effect of food on drug absorption. Unlike locally acting formulations, systemically acting transdermal formulations need not be applied at the target site, so dosing is simple and the burden is not on one area of the skin.

A multicenter, randomized, double-blind, placebo-controlled, comparative study to evaluate the efficacy and safety of newly developed diclofenac patches in patients with cancer pain.

This phase III multicenter randomized double-blind placebo-controlled comparative study evaluated the efficacy and safety of diclofenac sodium patches for the treatment of cancer pain. The study consisted of a 2-week to 4-week open-label dose-titration phase and a 4-week double-blind phase. In the double-blind phase, patients who were expected to continue treatment of cancer pain with nonopioid analgesics alone were randomized to the diclofenac sodium patch or placebo group.

An Open-Label Study of the Pharmacokinetics and Tolerability of Once-a-Day Fentanyl Citrate Patch in Japanese Pediatric and Adolescent Patients with Cancer Pain.

Background: Transdermal fentanyl is not yet approved for pediatric and adolescent use in Japan.

Objective: Serum fentanyl concentration and the safety and efficacy of once-a-day fentanyl citrate patch were investigated in pediatric and adolescent patients with cancer pain.

Methods: In this open-label, uncontrolled study, cancer patients aged 2-19 years being treated with strong opioid analgesics were switched to fentanyl citrate patch for 2 weeks.

Long-term study of ropinirole patch in Parkinson's disease patients with/without basal l-dopa.

Introduction: A dopamine agonist patch could be an important treatment option for Parkinson's disease. This study evaluated the long-term efficacy and safety of the ropinirole hydrochloride patch. The steady state plasma ropinirole concentration was also assessed.

Efficacy and Safety of Fentanyl Citrate Patch, Including a Low-Dose 0.5 mg Formulation, in Opioid-Naïve Patients with Cancer Pain.

Background And Objective: The use of transdermal fentanyl for opioid-naïve patients is restricted, however, transdermal fentanyl is a useful opioid analgesic for patients in whom oral administration is difficult or for those with renal failure. In this study, the efficacy and safety of fentanyl citrate patches was evaluated in opioid-naïve patients suffering from cancer pain.

Methods: An open-label uncontrolled study was conducted in opioid-naïve patients with cancer pain unable to be controlled by non-opioid analgesics.

Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet in Advanced Parkinson's Disease.

Background: A dopamine agonist patch is an important treatment option for PD.

Objectives: A randomized, double-blind, parallel-group, placebo-controlled trial was conducted to evaluate superiority of ropinirole hydrochloride patch over placebo and noninferiority to ropinirole hydrochloride extended-release tablet.

Methods: PD patients using levodopa received ropinirole patch (up to 64 mg/d), ropinirole tablets (up to 16 mg/d), or placebo once-daily (double-dummy technique).