![]() Postmarketing safety data of the previous CFC version were also evaluated during the FDA review of the new drug application for Primatene ® MIST HFA. With regard to safety of Primatene ® MIST HFA, the most common adverse events reported were tremor, followed by chest discomfort. ![]() The efficacy of Primatene ® MIST HFA was comparable with that of Primatene ® MIST CFC. The results demonstrated significant bronchodilator efficacy of Primatene ® MIST HFA compared with placebo, with a between-group difference of 27.83 AUC 0-6hr of Δ%FEV1 (95% CI, 11.99-43.68 P <.05). The primary efficacy end point studied was the mean area under the curve (AUC) of the change in 1-second forced expiratory volume (Δ%FEV1) from same-day, predose baseline to 6 hours post dose (AUC 0-6hr of Δ%FEV1) at week 12. The results demonstrated that Primatene ® MIST HFA is safe and effective in relieving mild symptoms of intermittent asthma in adolescents and adults. The duration of treatment was 3 months, followed by a 3-month safety extension period. Patients were randomized 4:1:1 to receive Primatene ® MIST HFA 250 mcg (two 125 mcg inhalations), placebo, or Primatene ® MIST CFC 440 mcg (two 220 mcg inhalations), respectively, 4 times daily. The efficacy and safety of Primatene ® MIST HFA were established in a phase 3, randomized, double-blind, placebo- and active-controlled (Primatene ® MIST CFC), parallel-group study of patients 12 years and older with stable asthma. SUMMARY OF CLINICAL STUDIES AND POSTMARKETING DATA FOR PRIMATENE ® MIST The previous version was indicated for patients 4 years and older. 1,2 Primatene ® MIST HFA is approved for patients 12 years and older. 2 Critical instructions and a dose indicator are provided directly on the inhaler. 2 Further, because Primatene ® MIST HFA is a suspension, the inhaler must be shaken prior to each use to ensure that the proper dose is administered. 2 The efficacy remains comparable at the lower dose. 2 Both contain the same active ingredient, L-epinephrine however, Primatene ® MIST HFA contains a 43% lower dose of epinephrine than the previously marketed CFC version. ![]() There are several differences between Primatene ® MIST CFC and the new Primatene ® MIST HFA. 1,6 It delivers 0.125 mg of L-epinephrine per spray and contains inactive ingredients such as dehydrated alcohol (1%), HFA 134a, polysorbate 80, and thymol. Primatene ® MIST HFA is a metered-dose inhaler that is FDA-approved for OTC use for the temporary relief of mild symptoms of intermittent asthma, such as wheezing, tightness of chest, and shortness of breath. 6 For the convenience of this guide, the new Primatene ® MIST containing HFA will be referred to as Primatene ® MIST HFA and the previous version will be referred to as Primatene ® MIST CFC. The product was launched in December 2018. 2,4,5 The new formulation of Primatene ® MIST uses hydrofluoroalkane (HFA) as the propellant, and it was approved by the FDA for OTC use on November 7, 2018. During discussions with patients, pharmacists can counsel them on important points regarding safety, appropriate dosing and use to guide them regarding treatments.Ī prior formulation of Primatene ® MIST, approved by the FDA more than 50 years ago, used chlorofluorocarbon (CFC) propellant and was subsequently discontinued in 2011 as a part of the overall efforts of the Montreal Protocol of Substances that Deplete the Ozone Layer and the Clean Air Act of 1990 to phase out ozone-depleting CFC propellants. 2 Pharmacists are ideally positioned to answer questions, educate patients, and offer support to patients who are interested in using the new and improved Primatene ® MIST. 1,2,3 Studies have demonstrated that it is safe and effective in patients with intermittent asthma when used as directed. The new Primatene ® MIST, an epinephrine inhalation aerosol bronchodilator (0.125 mg L-epinephrine), is the only FDA-approved, over-the-counter (OTC) asthma medicine inhaler for the temporary relief of mild symptoms of intermittent asthma. This article is sponsored by Amphastar Pharmaceuticals, Inc.
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