New Rx Acute Migraine

Posted on Apr 29, 2010 in Patient Care | 1 comment

Sumavel™ DosePro™: The Newest Addition to Acute Migraine Care

Sumavel™ DosePro™ was approved by the FDA in July of 2009 as a novel needle-free device for delivering 6 mg of sumatriptan into the subcutaneous tissue for treatment of migraine with or without aura and cluster headache. Approval was based on the device demonstrating bioequivalence with already approved subcutaneous delivery systems; hence, the earlier efficacy trials from the 1990s were considered to provide the established efficacy data.

The devise works by propelling a narrow column of liquid sumatriptan with sufficient velocity to puncture the skin and deposit the drug into the subcutaneous tissue. The puncture is similar to that created by a small gauge needle and the injection time is approximately 0.1 second. The propellant is nitrogen gas which is vented out the side of the devise resulting in a short hissing sound.

The device is simple to use requiring 3 steps for delivery: 1) snap off the sterile protective cap; 2) arm the device by cocking a lever on the side of the device; and, 3) pressing the device against the skin of the thigh or abdomen. There is a noticeable “pop” when the device deploys and, frequently, significant stinging that lasts several seconds. It is wise to prepare patients for both because being needle-free does not mean the device is painless.

In clinical trials the device was found simple to use and without serious side effects. There were reported instances of minor bleeding, bruising, and tissue swelling at the site of injection. With detailed monitoring, 42% reported bleeding which was generally minimal, 86% had short-lived swelling, erythema in up to 53% that generally resolved within 24 hours, and bruising in 11% immediately after the injection but only 3% by 1 hour.[1]

In earlier subcutaneous sumatriptan clinical trials, the efficacy for pain relief was reported at 70% at 1 hour (moderate to severe pain decreasing to mild or no pain) and approximately 80% by 2 hours. Approximately 50% were pain free within 1 hour.[2] These results are assumed to be the same when sumatriptan is delivered by the Sumavel™ DosePro™ needle-free system.

In another study used for regulatory support, simple education with demonstration of use resulted in 98.1% of users successfully utilizing the device with their first attempt. Also 98.4% agreed or strongly agreed the instructions were adequate. Most chose to use the thigh as the injection site.[1]

The author considers subcutaneous triptans to be an essential component of the “tool box” for most patients with migraine. Most patients with migraine have at least some attacks for which oral medications are inadequate or ineffective. In instances when migraine comes on abruptly, in association with significant nausea, or when treatment is delayed such as can happen with early morning migraine, the parenteral administration can be highly effective and minimize disability. Perhaps the other attribute of this specific device is its ease of use. Questions remain though about patient acceptability and third party coverage, valuable coupons are provided by Zogenix and Astellas in an effort to defray cost.

So now it is your turn to give us your feedback:

1. How many of you have been provided information on this new delivery system?
2. How many have prescribed it?
3. Are you finding the device to be covered by third parties?
4. How satisfied are you with the device?
5. How satisfied are your patients?
6. What has your feedback been from your patients?
7. Any advice you have for your colleagues on educating patients that are prescribed this device?

Roger Cady, MD
Published on April 29, 2010

References

1. Brandes JL, Cady RK, Freitag FG, et al. Needle-free subcutaneous sumatriptan (Sumavel DosePro): bioequivalence and ease of use. Headache. 2009;49(10):1435-1444.
2. Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs H. Treatment of acute migraine with subcutaneous sumatriptan. JAMA. 1991;265:2831-2835.