GUEST COLUMN: Enable Injections: New Body Worn Injectors Change Beliefs About Subcutaneous Drug Delivery

New Body Worn Injectors Change Beliefs About Subcutaneous Drug Delivery
Human Factor studies yield surprises
January 14, 2015
By Michael D. Hooven, CEO of Enable Injections

As former U.S. Surgeon General C. Everett Koop famously said, drugs don’t work in patients who don’t take them.

Adherence could be a particularly vexing problem for the 900 or more biologics in development or on the market. These large-molecule formulations must be taken in large doses, up to 20 ml, to be effective. By 2016, biologic drugs to treat cancer, autoimmune deficiencies, blood disorders and a range of other conditions are expected to account for 50 percent of the top 100 drugs.

In a major advance, a brand new class of injection technology, the body worn high- volume bolus injector, makes it possible for patients to self-inject these high volume drugs in the comfort of their homes. Developers of these new injectors, such as Enable Injections, have designed drug delivery devices for these big payloads that patients will want to use. Because these drugs will be administered by the patients in a home environment without the supervision of a healthcare professional, the U.S. Food and Drug Administration is placing a great emphasis on Human Factor (HF) studies.

These HF studies are designed to insure that the device will deliver the drug to the patient in a safe and reliable manner.

Human Factors studies challenge long-held pharma beliefs

According to the over 20 Human Factor studies conducted by Enable Injections, this emerging high volume bolus injector technology is challenging two strongly held pharmaceutical industry beliefs: 1) that a device should be prefilled instead of user filled, and 2) that an injection should be done as quickly as possible.

In the HF studies patients consistently preferred a user-filled device that automatically warms the drug while the injector fills, eliminating the unpopular 30-minute warm up time that is often necessary with refrigerated pre-filled injectors. Patients also opted for a longer injection time if the injection was more comfortable. In fact, patients said injection time is irrelevant if the injection is not painful and doesn’t interfere with daily activities.

The result of focusing on patient needs and preferences is an Oreo-sized wearable high volume bolus injector that enables easy, comfortable subcutaneous injection of biologic drugs at home or office.

The body worn injector also offers the potential to save pharmaceutical companies months or years of development time and significantly reduce health system costs by eliminating the need for a professionally mediated infusion at a healthcare facility.

The new injectors optimize patient comfort by incorporating flow and pressure-control technology. Injecting at a pressure exceeding 14 psi can occur with an injection method that relies on controlling rate of injection rather than pressure. A 14+ psi injection can be painful. It can be damaging to tissue. The Enable Injector, based on painless injection technology, is engineered to sense tissue pressure and, in a uniquely personalized approach, automatically adjusts the flow rate to the particular patient tissue to maintain a comfortable injection pressure throughout.

HF studies also suggest that patients prefer injectors that allow them to be ambulatory during the injection.

A major advantage of some body worn bolus injectors is that patients can go about their normal activities during injection. The devices are usually adhered to the abdomen where they can be discreetly worn under clothing, out of view. Audible/tactile/visual cues signal when the injection is complete, and the injector can be removed when convenient.

With FDA approval contingent on considering delivery devices in combination with the biologics for which they are intended, a device engineered based on Human Factors studies that assures safe use and easy compliance is key. That these new devices coming to market also serve the pharmaceutical industry in numerous ways portends rapid adoption by all stakeholders and a true treatment advance that could impact outcomes positively while lowering costs of drug administration.

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