FDA Approves Botox for Lower Limb Spasticity

BOTOX – Lower Limb Spasticity

The FDA has approved the use of BOTOX (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to help decreased muscle stiffness in ankle and toe muscles.

The approval was based on a large, international program including a phase III multi-center, double-blind, randomized, placebo-controlled trial evaluating BOTOX’s safety and efficacy in over 500 patients with lower limb spasticity following stroke. The study compared doses of 300 to 400 units divided among ankle and toe muscles, as well as placebo.

Overall, significant improvements in muscle stiffness were noted at weeks 4 and 6 among patients using BOTOX.

Adverse reactions included arthralgia, back pain, myalgia, upper respiratory tract infection, and injection site pain.

Kyprolis – Multiple Myeloma

The FDA has approved Kyprolis (carfilzomib) for the treatment of patients with relapsed or refractory multiple myeloma in combination with dexamethasone or with lenalidomide plus dexamethasone.

The approval is based on results from the Phase III head-to-head ENDEAVOR study in which patients treated with Kyprolis showed 50% greater progression-free survival compared to those receiving bortezomib and dexamethasone, the current standard of care.

The most common side effects were fatigue, insomnia, pyrexia, and thrombocytopenia.

Integra Omnigraft Dermal Regeneration Matrix – Diabetic Foot Ulcer

The FDA has approved Omnigraft for the treatment of certain diabetic foot ulcers.

The device, made from silicone, cow collagen, and shark cartilage, is placed over the ulcer, providing an environment for new tissue to grow and for the wound to heal.

The approval is based on a study in which 51% of patients treated with Omnigraft had healed ulcers within 16 weeks compared to 32% of those treated with standard care alone.

Adverse reactions included infections, swelling, nausea, and worsening ulcers.

—Michael Potts

References:

Allergan. U.S. FDA Approves BOTOX® (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults [press release]. January 22, 2016. http://www.allergan.com/news/news/thomson-reuters/u-s-fda-approves-botox-onabotulinumtoxina-for-the

Amgen. FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma [press release]. January 21, 2016. http://money.cnn.com/news/newsfeeds/articles/prnewswire/MM03257.htm.

FDA. FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers [press release]. January 7, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm.