WINSTON-SALEM, N.C.– The announcement by the Food and Drug Administration (FDA) that it has approved Botox® (onabotulinumtoxinA) to treat upper limb spasticity (excessive muscle tightness) following a stroke is great news for the millions of stroke survivors in the United States, said Allison Brashear, M.D., professor and chair of the Department of Neurology at Wake Forest University Baptist Medical Center.
Brashear, head of the spasticity clinic at Wake Forest Baptist, is a nationally known expert in the treatment of spasticity.
“Stroke survivors often have trouble getting dressed and cleaning their hands,” Brashear said. “Injections of Botox can relieve the tightness that interferes with these activities of daily living. It’s important for family members, physicians and other caregivers to know that Botox is a very effective treatment for spasticity.”
Brashear and colleagues conducted clinical trials showing Botox to be an effective treatment for the condition. Her research findings were published in the New England Journal of Medicine in 2002. A follow-up study published in the journal Neurology in 2004 demonstrated repeated benefits of the injections in patients with post-stroke spasticity.
“Final results from our multi-center study show that repeated treatments of Botox over one year is well tolerated and results in a significant decrease in spasticity following stroke,” Brashear said. “Patients also noted an improvement in dressing, hand hygiene, limb position and pain after the injections. Significant improvements in these outcome measures indicate a better quality of life for post-stroke patients suffering from post-stroke spasticity.”
Spasticity is a disabling condition following a stroke or brain injury, resulting in tightness that interferes with movement of the limb. Often patients are unable to dress themselves, wash their hands or eat without assistance. Brashear’s study was the largest study to date to evaluate treatment with Botox for post-stroke spasticity. Brashear and colleagues reported that one-time injections of Botox are safe and effective in people with wrist and finger spasticity after a stroke.
“Our study showed that treatment with Botox can lessen these disabling symptoms without treatment-limiting side effects, which in turn improves the ability of stroke patients to perform essential activities of daily living, including dressing themselves, maintaining good hand hygiene, and reaching for and grasping everyday objects,” Brashear said.
About 58 percent of stroke survivors experience post-stroke spasticity, and only 51 percent of those are receiving treatment for that condition, according to the National Stroke Association.
“Early intervention with effective therapies is absolutely vital to prevent the profound disability that afflicts many stroke patients,” said Brashear. “Having data to support a safe and effective profile for long-term treatment with Botox is significant for patients and caregivers. Many oral anti-spasticity medications are associated with systemic side effects such as sedation, mental confusion, dizziness and muscle weakness, all of which can seriously hinder rehabilitation after a stroke.”
The study was funded by Allergan Inc., the pharmaceutical company that developed Botox. Brashear’s co-researchers were Elie Elovic, M.D., of Kessler Medical Rehabilitation Research and Education Corporation, West Orange, N.J., Darryl Kaelin, M.D., of the Shepherd Center, Atlanta, Ga., and Robin McIntosh, B.S., Amanda VanDenburgh, Ph.D., Catherine Turkel, PharmD, M.B.A., and Frederick Beddingfield III, M.D., Ph.D., with Allergan Inc.
Brashear is also a paid consultant for Allergan Inc. to help develop their spasticity program.