Advancements, Challenges, and Opportunities in Developing Respiratory Drug Delivery Devices

Highlights from the roundtable:

To simplify the use of inhalers, many companies have adopted an open-inhale-close (OIC) model for their products. However, a lack of standardization remains across different inhaler designs and can result in patient confusion. Addressing this issue will require enhanced training programs to improve patient proficiency in using inhalers.

CDP perspective:

Multi-dose respiratory devices offer unparalleled cost-per-dose benefits compared to many other delivery methods, except for oral drugs. However, within the three major inhaler families (pMDIs, DPIs and SMIs), there are significant differences in how the user accesses the drug and gets an effective, consistent dose. With some inhalers, opening a mouthpiece cover will expose the dose- whereas other inhalers require the user to advance a dose drive as well. Even if the patient can reliably access the dose, variations of inhalation technique can significantly alter the dose profile the patient receives. While it helps that many medications have a wide therapeutic index, erring towards excess dose rather than under dose, users can become confused about how to use their inhalers. Training, frequent check-ups, and easy access to user guides, videos, and healthcare professional (HCP) involvement is critical.

This article from The International Journal of COPD explores inhaler adherence with insight for improving patient compliance: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10697822/

Highlights from the roundtable:

Technology demos for connected inhalers have shown great promise, but this extra functionality comes with additional cost and complexity. The regulatory demands around patient privacy present a major obstacle. The investment required must be supported by tangible enhancements in patient outcomes. Furthermore, maintaining patient confidentiality and ensuring sustainability remain challenges. Numerous third-party tools are available for connecting inhalers and offering patient support but articulating a clear patient benefit from this data tracking hasn’t been demonstrated yet. The committee members also observed that getting users to pair a device with their phone could become another barrier to adoption.

CDP perspective:

Inhalers may seem like a natural fit for connectivity due to being multi-dose devices used to manage chronic conditions and prevent the emergence of life-threatening symptoms. However, given the cost considerations associated with developing respiratory devices, it’s essential for connectivity features to demonstrate tangible benefits. One way to prove their worth is by showing improvements in patient outcomes such as reducing adverse events for patients, especially those that have measurable economic impacts, like the cost of hospitalization. The challenge lies in convincing patients of the benefits of using connected devices and ensuring their consistent engagement with the technology to gather relevant data. Regarding sustainability, many pharma companies with a portfolio of respiratory drugs are getting a lot more serious about their environmental footprint. Against this focus on environmental impact, how can electronics (which aren’t essential to safe and effective delivery) be justified?

Highlights from the roundtable:

Any new low global warming potential (GWP) propellant for pressurized metered-dose inhalers (pMDIs) necessitates new testing, including a Phase 3 clinical trial, incurring additional time and cost in the effort to move away from the current gases used. EPAG experts were encouraged to note that the FDA is spearheading discussions on the updated regulations for drugs with these new propellants, with hope that this may streamline the process in future.

CDP perspective:

The current emphasis is on bringing legacy pMDI-based products to the market using one of the two low GWP gases under consideration – Honeywell’s 1234ze and Koura’s 152a. This shift in the market can have broad implications for inhaler construction, requiring extensive testing and confirmatory clinical trials. While the transition to low GWP gases is extremely important, some industry insiders believe that it is currently stifling innovation in the pMDI space. It is anticipated that once the new gases are established, innovation will benefit from the advancements made in transitioning to low GWP gases, expediting the process of bringing new treatments to previously underserved patient groups much quicker.