Drug device combination products (DDCPs) refer to therapeutic agents or pharmaceutical products that combine a drug with a medical device. These innovative combination products are helping revolutionize patient care across many therapeutic areas. DDCPs aim to deliver drugs in a more targeted, controlled, or sustained manner to maximize therapeutic benefit. With the advances in drug delivery technologies, DDCPs are playing a key role in improving treatment outcomes for patients.

Regulatory Overview of DDCPs

The regulatory approval process of DDCPs is unique as they fall under the shared jurisdiction of the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The primary mode of action of the combination product determines whether it will be regulated under drug or medical device authorities. CDER regulates the drug component and ensures its safety and efficacy, while CDRH assesses the device part for its performance and controls. Drug device combination products integrate pharmaceutical agents with medical devices to enhance therapeutic outcomes and patient care.

FDA teams work collaboratively to determine the most appropriate product-specific regulatory requirements and review the totality of the product’s risks and benefits. With clear regulatory guidelines in place, DDCPs have gained prominence.

Continuous Glucose Monitoring DDCPs

One arena where DDCPs have revolutionized care is diabetes management. Continuous glucose monitoring (CGM) systems integrate a subcutaneous sensor, transmitter and receiver to measure and display real-time glucose levels every few minutes. Notable CGM DDCPs include Dexcom G6 and Abbott FreeStyle Libre, which have advanced interstitial fluid glucose monitoring.

These non-invasive systems avoid the pain and inconvenience of fingerstick testing. They alert users of potential hyperglycemia or hypoglycemia, facilitating timely treatments. CGM data can also be uploaded to smart devices and shared with care teams for remote monitoring. Studies show CGM significantly improves glycemic control and reduces adverse events like severe hypoglycemia. They are transforming diabetes management by empowering patients.

Injectable Drug Delivery DDCPs

Novel drug delivery DDCPs are revolutionizing treatment of chronic diseases by providing efficacious and convenient therapy through injection devices. Auto-injectors were among the earliest forms gaining prominence. They house prefilled syringes or cartridges along with spring-powered mechanisms to deliver subcutaneous or intramuscular injections automatically upon activation.

Notable auto-injectors include EpiPen for emergency epinephrine treatment of anaphylaxis and Copaxone for multiple sclerosis. Users need minimal dexterity or hand strength, improving convenience. Other biologics are also being developed in auto-injector formats for arthritis, cancer and more. Implantable drug delivery ports provide long-term subcutaneous access for safe, controlled release of medication over weeks to months.

Inhaled Drug Delivery DDCPs

Pulmonary drug delivery via DDCPs is being widely explored for its ability to treat respiratory diseases locally as well as deliver systemic drugs non-invasively. Metered dose inhalers and dry powder inhalers have enabled effective inhaled therapies for conditions like asthma and COPD for decades by delivering drugs like albuterol and corticosteroids.

Novel inhalable DDCP formulations combining biologics with pulmonary drug delivery devices aim to improve lung targeting as well as enable systemic delivery of macromolecules. For instance, inhaled insulin is being developed as a non-injectable option comparable to injections in efficacy and safety. Continued innovation in miniaturized, portable inhalation systems can overcome pharmacological barriers and expand therapeutic possibilities.

Cardiovascular DDCPs

Drug eluting stents, which have a coating containing an anti-proliferative drug like paclitaxel or sirolimus, were pivotal in revolutionizing percutaneous coronary intervention outcomes after approval over 15 years ago. By locally administering the drug at the stent site, they significantly reduced in-stent restenosis rates when compared to bare-metal stents. Over 4 million patients worldwide have benefited from these definitive DDCPs.

More recent cardiovascular DDCP innovations combine drug delivery pumps, sensors and catheters to transform atrial fibrillation treatment. The Watchman device, for instance, is an implantable filter combined with anticoagulation therapy to reduce stroke risk in non-valvular atrial fibrillation. Further progress blending drug and device concepts can help modernize therapies across cardiology.

In summary, DDCPs are playing an increasingly crucial role in advancing patient care. By pairing drugs with medical devices, they achieve targeted delivery, improve usability and convenience, and optimize therapeutic outcomes. Continued regulatory clarity and investment in the multidisciplinary DDCP field will be critical to developing tomorrow’s breakthrough combination products. With their ability to revolutionize entire therapeutic areas, DDCPs will remain central to revolutionizing medicine.

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