Wednesday, January 27, 2010

Walking Pill for MS

FDA Approves the Walking Pill for Multiple Sclerosis
As of Friday afternoon, a long awaited addition to our arsenal of MS symptomatic drugs has been approved.

We had a conversation about Ampyra which is a timed-release version of the drug 4-Aminopyridine (and formerly known as Fampridine SR), last May. At that time the drug was being resubmitted to the FDA for approval (rejected, originally, due to “formatting issues” during the application process).

This drug is thought to increase signal conduction by blocking tiny pore-like potassium channels on nerves of the central nervous system (CNS).

The time-released part of the drug is what is new, for those of you who have been getting 4-Aminopyridine from compound pharmacies.

Phase III clinical trials suggest that some 34-43 percent of people taking Ampyra had positive results in the areas of leg strength and walking speed. An average of 25 percent increase in walking speed!

No drug, of course, is without risk. Potential side effects include back pain, dizziness, headache, insomnia, urinary tract infection (UTI), fatigue, nausea, balance disorder and falls (which may or may not have been increased by subjects trying to walk without their assistive devices). There were also enough cases of seizure that anyone who has a history of seizure disorder are warned NOT to take Ampyra.

Patients with moderate or severe renal disorder (kidney issues) are also warned against taking Ampyra as this could lead to an unsafe level of the drug in the body.

The drug is administered in capsule form and, in clinical trials, was dosed every twelve hours.

The price of prescription Ampyra has yet to be announced, but many in the MS world are expecting a net cost around $10,000 per annum and will likely be ready to dispense in March of this year.

When we last discussed this drug, several of you commented about your use of the compounded version of the drug. I’d be interested to hear more from you, as well as those of you who may consider Ampyra in your treatment regime… or not.

Wishing you and your family the best of health.