Where Drug Delivery Falls Short And What The Industry Should Do Next

By Joel Latham, president & CEO of Incannex

Drug delivery has improved significantly over the last two decades with better biologics, smarter devices, and more targeted therapies. However, many patients still struggle with treatments that are difficult to tolerate, inconvenient to use, or poorly suited for long-term adherence, although many treatments only work when patients can and will use them consistently. Too often, success is measured at approval, while the real test happens later in homes, workplaces, and clinics. If patients abandon therapy or use it inconsistently, even highly effective products can fall short.

The next phase of progress in drug delivery will come from solving practical problems, designing around patient behavior, simplifying treatment pathways, using devices only when they add clear value, and focusing on disease areas where current standards of care are not meeting patient needs.

Efficacy Alone Is Not Enough

Clinical efficacy remains essential, but it is only one part of the equation. Many therapies perform well in controlled studies and still struggle in real-world settings. Some treatments are uncomfortable, while others require extensive setup or training. Many disrupt sleep, work schedules, travel, or daily routines. Over time, those barriers reduce adherence and limit outcomes.

Obstructive sleep apnea is a clear example. It is a common and serious condition linked to cardiovascular risk, metabolic dysfunction, fatigue, and lower quality of life. Standard device-based therapies can be highly effective, but many patients find long-term use challenging. Some never begin treatment, while others stop early or use therapy inconsistently. This is not unique to sleep medicine, and across chronic disease categories, the same lesson applies. If treatment depends on ideal patient behavior, adoption will always be limited.

Start With The Patient

Drug delivery strategies often begin with the technology itself. Teams discuss novel platforms, delivery systems, or connected devices before fully defining the patient problem they are trying to solve. The better starting point is to ask what prevents consistent treatment today.

Some barriers include fear of injections, complex dosing schedules, side effects, social stigma, poor fit with daily life, or cost. Once those hurdles are cleared, product design becomes more practical and more effective. In some cases, the answer may be an oral therapy instead of a device. In others, it may be less frequent dosing, simpler packaging, or fewer administration steps. Innovation should be judged by whether it removes friction for the patient instead of focusing on how advanced the technology appears.

Combination Products Solve A Real Problem

Combination products can offer incredible benefits, but they should be developed with discipline. Combining ingredients or components can increase regulatory complexity, manufacturing demands, and cost. If the benefit is modest, the added burden may not be justified.

The strongest combination products address multiple drivers of disease in a way that a single agent cannot. That approach is especially relevant in chronic conditions with complex underlying biology. At Incannex, we have focused on fixed-dose combinations intended to target more than one pathway while maintaining a practical treatment format for patients. Our lead candidate in obstructive sleep apnea, for example, combines two known agents in a single oral therapy under investigation for patients who need an alternative to existing options. Combination products should improve outcomes or usability in a meaningful way; if they do not, added complexity rarely results in lasting value.

Use Devices With Purpose

Drug-device combinations and digital tools can improve care when they are thoughtfully designed. They can also create new barriers when they add unnecessary steps or complexity. A connected injector, wearable monitor, or companion app may look compelling in development plans, but patients and providers will quickly disengage if setup is difficult or the data does not lead to action.

The most effective device integrations are typically simple to use, reduce effort for patients or providers, and generate information that improves decisions or outcomes. If a device does not clearly deliver one of those benefits, teams should reconsider whether it belongs in the product strategy.

Regulatory Planning Should Start Earlier

Another common mistake is treating regulatory strategy as something that happens later in development. By that stage, many of the most important decisions have already been made, including formulation choices, endpoint selection, manufacturing plans, and device design. For combination products or repurposed compounds, early planning is especially important. Existing ingredients do not automatically create a simple approval path. Regulators still need clear evidence of safety, efficacy, quality, and consistency.

Strong programs build regulatory thinking into the earliest stages of development. That includes a clear target product profile, practical endpoints, manufacturing readiness, human factors planning where needed, and early engagement with regulators. Good regulatory strategy reduces avoidable delays and helps teams generate the right evidence the first time.

Measure Success

Traditional clinical endpoints remain critical, but they should be paired with measures that reflect everyday patient experience. Ask questions such as:

• Did patients stay on therapy?
• Did fatigue improve?
• Was treatment manageable over time?
• Did quality of life improve?
• Would patients choose to continue?

The answers to these questions are particularly important in chronic disease, where long-term persistence often determines long-term outcomes.

In Incannex’s clinical work, patient-reported outcomes have provided useful context alongside objective measures, helping show whether a treatment improvement is meaningful in daily life. That type of evidence can be valuable for everyone involved, including regulators, physicians, payers, and patients.

The Opportunity Ahead

The biggest opportunities in drug delivery will come from solving common practical problems in areas where existing treatments are underused, poorly tolerated, or too difficult to maintain. The companies that lead the next decade will be those that combine strong science with real-world usability. They will build therapies patients can realistically follow, clinicians can confidently prescribe, and health systems can support at scale. Drug delivery, in many cases, is what determines whether innovation reaches its full potential.

About The Author

Joel Latham has served as the chief executive officer, president, and director of Incannex Healthcare Inc. since July 2023. He brings more than 20 years of senior management and operations experience in both public and private sectors. Previously, he was the CEO and managing director of Incannex Australia, where he played a key role in the company’s growth and its successful transition to Nasdaq. Joel has also held senior leadership roles in corporate strategy and global market development at Mars Foods, Tabcorp, and Philip Morris International.