The groundbreaking approval of Exubera signals that exciting times are ahead for the pulmonary route of drug delivery in many disease areas.
Many drugs, such as hormones, that are currently used to treat a range of chronic diseases, can only be given by injection and an effective alternative delivery method will be welcomed in many patient groups.
The January approval of Exubera is the first time that a drug has been approved using pulmonary delivery to treat a systemic disease and the decision now opens the door for this delivery method to be used in wider disease applications.
"In the current climate, it is tough to get new drugs approved, particularly inhalation products, due to the limitations of this route," said Leslie Williams, an inhalation technology expert and president & CEO of the specialist pulmonary inhalation technology company Ventaira.
"One can't underestimate the opportunity this presents for new treatments to be developed that can be delivered by the lungs to treat diseases that are not related to the lungs," she told In-PharmaTechnologist.com.
The pulmonary drug delivery market is currently worth $13bn (€10.5bn) and is tipped to grow to $25bn over the next decade as it encompasses new therapeutic areas, with diabetes playing a large part of that growth.
Other budding therapeutic areas include multiple sclerosis (MS) and certain antibiotics and antivirals.
The approval is set to spark revival in the drug reformulation business, which had been growing steadily between 2000-03 but has since slowed down.
One company working in this area is Ventaira, focused on finding novel formulations of existing off-patent compounds that can be delivered by the pulmonary route to treat chronic diseases.
Later this year, Ventaira will begin Phase II trials with its new inhalation device and formulation of a steroid for asthma/COPD called Mystic.
According to Williams, the device will deliver the drug in a consistent dose with 80 per cent accuracy, compared to current devices that are inefficient in delivering an adequate dose, with only 10 to 15 per cent of the drug getting into the lungs.
"Reformulation is an area that many big pharma companies are now looking at as a way to manage the lifecycle of existing blockbuster drugs," said Williams.
"There is enough room for all of us in this space, as there is no one drug delivery device that does everything," she said.