New Long-Acting Beta-2 Agonist Bronchodilator in the Respimat Formulation for COPD

 In COPD, Inhalers

Striverdi Respimat was given FDA approval on July 31, 2014 and is indicated for use as a long-term, once-daily maintenance bronchodilator treatment of COPD, including chronic bronchitis and/or emphysema. The active ingredient, olodaterol, is a long-acting beta2-adrenergic agonist (LABA) bronchodilator that is formulated as a liquid spray for use via the latest type of inhalation device called a Respimat.  The recommended dose is 2 inhalations once daily.  Each actuation of the device delivers 2mcg of olodaterol.

Warnings/Side Effects

Thus far, Striverdi Respimat has only been indicated for use in COPD and has not been studied in patients with asthma.  As with all LABA, it is not for use for the relief of acute symptoms and is contraindicated in patients with asthma without use of a long-term asthma control medication.  Striverdi Respimat should not be initiated in patients with acutely deteriorating COPD and should be used with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis or sensitivity to sympathomimetic drugs. A life-threatening paradoxical bronchospasm can occur and Striverdi Respimat should be discontinued immediately.  The most common adverse reactions include: nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain and arthralgia.

Safety and Efficacy

Compared to other LABA bronchodilators (formoterol, indacaterol, salmeterol, and arformoterol), olodaterol has demonstrated similar safety and efficacy.

Comparison Chart

Advantages of Striverdi Respimat

Striverdi Respimat is being promoted with two advantages over the current LABA on the market.  The first advantage is Striverdi Respimat is dosed as once daily.  All of the other LABA, aside from Arcapta Neohaler (indacaterol), are dosed BID.

The second promoted advantage of Striverdi Respimat is the drug delivery system.  The Respimat Inhaler system is a multi-dose, propellant-free, hand-held liquid inhaler.  The device delivers a pre-measured amount of medication in a slow-moving mist, which the patient inhales through a mouthpiece. This method of medication delivery allows more of the drug to enter the lungs instead of the esophagus compared to devices with a propellant, such as a Metered Dose Inhaler (MDI).  Compared to the LABAs that come as a Dry-Powder Inhaler (DPI) (formoterol, indacaterol and salmeterol), a patient requires less force to inhale the medication. There have also been studies done which show that patients preferred the Respimat device over the other types of inhaled drug delivery devices, particularly if the patient has vision problems or arthritis.

These advantages are hoped to improve patient compliance with the medication.

Disadvantages of Striverdi Respimat

One of the main disadvantages of Striverdi Respimat is that in patients with COPD, positive inhalation pressure becomes a problem as the disease progresses. Most patients with severe or end-stage COPD are unable to inhale deep enough for inhalers to be effective and are generally switched to the nebulized form of LABAs (Brovana or Perforomist).

Another disadvantage of Striverdi Respimat is that it requires more training and education for a patient to use it correctly.  One clinical trial comparing a patient’s proper technique in using the Respimat or a MDI for the first time demonstrated that the proportion of patients demonstrating good technique was higher for the MDI (80%) versus the Respimat (48%).  By the final attempt, 98% of patients demonstrated satisfactory inhaler technique with the MDI compared to 96.4% with the Respimat.

Cost is a third disadvantage of Striverdi Respimat.  Similar to other long-acting beta agonist bronchodilators currently available (Arcapta, Foradil, Serevent),  Striverdi Respimat is also relatively expensive.  Cost for these products may range between $6 – $8 per day based upon average wholesale price (AWP).

Place in Hospice Therapy

Although Striverdi Respimat provides another option for patients with COPD that could help with improving patient compliance with the medication, it is largely cost prohibitive in the hospice setting.  Additionally, because of the training required for proper inhaler technique and the inability of most severe or end-stage COPD patients to have enough positive inhalation, this dosage form may not be as efficacious compared to other dosage forms.

References

  1. [Package Insert] Striverdi Respimat (olodaterol) Inhalation Spray. Boehringer Ingelheim Pharmaceuticals, Inc. Aug 2014.
  2. Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. Sept 2006;1(3):251-259.
  3. Feldman GJ, Bernstein JA, Hamilton A, et.al. The 24-h FEV1 time profile of olodaterol once daily via Respimat and fomoterol twice daily via Aerolizer in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419.
  4. Koch A, Pizzichini E, Hamilton A, et.al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jul 5;9:697-714.

 

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