Amphastar had sought to reintroduce its reformulated Primatene in But an FDA advisory committee voted against recommending approval , citing safety problems with the new device, as well as concerns about allowing patients with a serious illness to medicate themselves without having to consult a healthcare professional.
In , the FDA told Amphastar to conduct a "Human Factor validation study to assess consumers' ability to use the product without the guidance of a doctor or pharmacist," and to make changes to the product's labeling, before it would approve the product. In announcing the final approval on Thursday, top FDA officials said they were now satisfied that most patients would use the new Primatene Mist safely, while also acknowledging that risks still remain.
The new product is only appropriate for those with a diagnosis of mild, intermittent asthma. Pulled from the market in along with other asthma inhalers due to environmental concerns about their ozone-depleting chlorofluorocarbon CFC propellants, a CFC-free version of the drug was approved last November for over-the-counter OTC sale -- despite objections from the American Thoracic Society ATS , American Lung Association and other health groups that the move could led to suboptimal treatment and poorer asthma control if patients rely solely on the OTC medication to treat symptoms.
And now three asthma specialists, writing in the Annals of the American Thoracic Society , decry a lack of transparency leading up to the FDA's decision. The commentary noted that the FDA decision to allow Amphastar Pharmaceuticals to market its non-CFC version of the epinephrine inhaler for the treatment of symptoms related to "mild, intermittent" asthma was made without an official public comment period, advisory panel review, or input from medical societies.
Not entirely true: an FDA advisory committee did meet in to discuss Amphastar's CFC-free reformulation, and recommended against approval. As one retro commercial puts it: every second of an asthma attack can feel like an eternity. It might help to understand how Primatene Mist works. Almost everyone who has asthma uses some type of bronchodilator when symptoms arise.
As the name implies, the drug opens air passages in the lungs, expanding and relaxing them so people can breathe. The drug is delivered through an inhaler, although some types are delivered via a nebulizer mask. Primatene Mist comes in inhaler form and is small enough to be readily available as needed, on the go and unexpectedly. The active ingredient for both the original Primatene Mist and the newly-approved version is the same: epinephrine.
Epinephrine is good old-fashioned adrenaline. In the body, adrenaline is a naturally-produced hormone that helps us combat stress. For this reason, epinephrine is not usually sufficient or recommended for someone who suffers regular attacks. The brand has, in fact, reached generic name status, joining Kleenex, Bandaid, and Velcro. It was — and still is — the number one trusted name in asthma treatments.
As the old commercial went:. For the 26 million people who currently have asthma, a trusted brand brings a lot of comfort to their minds. So when the FDA pulled the product, there were a lot of unhappy people.
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