Medical Affairs Transformation in Specialty Pharma: Next-Level Collaboration at the Core.

Pharmaceutical companies with a medical mindset and an empowered Medical Affairs function are well equipped to meet the needs and expectations of patients and society. Yet, as capacity to understand and serve those needs accelerates, so too do expectations. Evidence-based practice, without delay, is expected throughout the development and delivery of medicine, healthcare, and information, and potential sources of evidence are legion.

OnabotulinumtoxinA Improves Pain in Patients With Post-Stroke Spasticity: Findings From a Randomized, Double-Blind, Placebo-Controlled Trial.

Context: Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life.

Objectives: To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX(®) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial.

Methods: Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks.

Functional goal achievement in post-stroke spasticity patients: the BOTOX® Economic Spasticity Trial (BEST).

Objective: Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity.

Methods: Prospective, 24-week double-blind study with an open-label extension. Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care, at baseline and at 12 weeks, if judged appropriate, with follow-up to 52 weeks.

A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines.

Background: Biological activity data indicate that the units of incobotulinumtoxinA are not equivalent to those of onabotulinumtoxinA.

Objective: This study compared 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA in the treatment of glabellar lines.

Methods And Materials: In this multicenter, randomised, double-blind study, subjects with moderate or severe glabellar lines received a single treatment with 20 units of onabotulinumtoxinA (n = 112), or 30 units of incobotulinumtoxinA (n = 112).

Double-blind, randomised, parallel group pilot study comparing two botulinum toxin type A products for the treatment of blepharospasm.

Botulinum neurotoxins (BoNTs) are the primary treatment for focal dystonias such as blepharospasm. Several different BoNT products are available in various countries. Given the variability in manufacturing, formulation, and unit doses of BoNTs, it is important to compare the profiles of products from different manufacturers.