New medications and devices update September 2008

1. Alvesco is ciclesonide in a metered-dose inhaler that uses HFA as the propellent. NycoMed's product was approved by the F.D.A. on 1/10/08. This fall, their U.S. partner Sepracor will begin marketing Alvesco in the U.S. Alvesco has 2 dose strengths: 80 mcg and 160 mcg 1-2 puffs twice per day. Alvesco is indicated for the maintenance treatment of asthma in patients 12 years old and in adults. Alvesco's device has a dose counter built-in, starting at 120.

2. Tilade (nedocromil sodium) will no longer be available. Tilade uses CFC as the propellent and the sale of CFC products will be banned on 1/1/09. No inhaler using HFA as a propellent is planned.

3. The F.D.A. has issued an advisory in response to reports that patients have mistakenly swallowed the capsules of medication containing Spiriva and Foradil, rather than put the capsules of medication in the devices and then inhaled the medication. No one suffered any harm, nor did the patients get any benefit from swallowing the medications. Please instruct your patients carefully in the use of devices and then check routinely for their understanding.

4. Three devices using HFA as a propellent for albuterol are approved. There is no generic equivalent. The devices and package inserts are not the same, despite using the same propellent and having the same medication. No data that I am aware of that indicates any have safety issues nor one has proven superiority.

5. Verus, the manufacturer of Twinject, declared bankruptcy during early 2008. Twinject was sold to and is promoted now by Sciele. The device is unchanged. (Medical offices may already be familiar with Sciele from their other products - Rondec and Orapred ODT.) To my knowledge, the price is unchanged also.

6. My preliminary research shows that insurance companies are beginning to recognize the code 95012, which is measurement of exhaled nitric oxide, to measure airway inflammation caused by asthma. There are two devices approved for sale by the F.D.A. in the U.S. (See prior posts.) More to follow later.