FDA Approvals: Pill Swallowing Cup, Humira Pen, SharpShield

Yael Waknine

June 27, 2006

June 27, 2006 — The US Food and Drug Administration (FDA) has approved a pill-swallowing cup to facilitate ingestion of medications and vitamins in patients who have difficulty swallowing; an autoinjection device with one-touch activation and an easy-to-grasp size and shape for patients requiring adalimumab therapy; and a syringe that features a subepidermal locking sheath to minimize the risk for accidental needlestick injuries in healthcare workers.

Pill-Swallowing Cup Minimizes Risk for Aspiration in Patients With Difficulty Swallowing

Registered with the FDA in June as a class 3 medical device, Pill Swallowing Cup, made by Oraflo Technologies, LLC, facilitates the ingestion of medications and vitamin supplements in individuals aged 4 years and older for whom swallowing pills is a challenge.

The product is intended to assist the swallowing reflex and benefit people of all ages and many conditions including autism, cancer, Parkinson's disease and attention deficit–hyperactivity disorder (ADHD). According to a company news release, results of a 2004 study conducted by Harris Interactive have revealed that 40% of US adults have difficulty swallowing pills despite their ability to swallow foods or liquids.

To use the device, the cup is filled halfway with water or other liquid and the lid placed securely. The pill is then dropped into the spout to rest above the liquid in a mesh with fluted ribs that minimizes surface contact with the cup. The angled mouthpiece extension allows the pill and liquid to be swallowed without backward tilting of the head, a feature of benefit to patients with neck pain or limited mobility.

The cup is compatible with all marketed sizes of pills and eliminates the need for pill crushing and cutting, thereby enabling proper administration of time-release and coated capsules and tablets.

Delivery Device (Humira Pen) Facilitates Administration of Adalimumab Therapy

On June 26, the FDA approved a device ( Humira Pen, made by Abbott Laboratories, Inc) for administering adalimumab in the treatment of moderate to severe rheumatoid arthritis and psoriatic arthritis. Adalimumab is currently administered as a subcutaneous injection using a specially designed prefilled syringe.

According to a company news release, the new device features one-touch activation and an easy-to-grasp size and shape for facilitated use in patients with manual inflammation or stiffness. It is expected to be available in the United States in August 2006.

The approval was based in part on data from the Trial Of Usability in Clinical settings of HUMIRA Autoinjector vs. Prefilled Syringe (TOUCH) study (n = 52), showing that approximately 90% of patients preferred the device over prefilled syringes, rating it more convenient and easier to use; 80% of patients reported it to be less painful.

Safety Syringe (SharpShield) Minimizes Risk for Needlestick Injuries

On June 21, the FDA approved a safety syringe ( SharpShield, made by Devon Medical) to minimize the risk for accidental transmission of blood-borne pathogens and other infectious agents via needlestick injuries.

According to a company news release, statistics from the Centers for Disease Control and Prevention show that nearly 1 million US healthcare workers suffer accidental needlestick injuries every year. Up to 90% of cases remain unreported, causing the occupational transmission of more than 20 blood-borne pathogens and other infectious agents.

Moreover, data from the World Health Organization suggest that needlestick injuries account for 40% of hepatitis B and hepatitis C virus infections and 2.5% of HIV/AIDS infections among healthcare workers.

The safety syringe features one-handed operation with passive deployment and a subepidermal locking sheath to eliminate exposure to the contaminated needle. Unlike auto-retractable syringes, it does not cause blood splatter upon activation or removal. The locking mechanism also prevents reuse of the needle, thereby creating additional protection from accidental exposure.

The syringe will be available in sizes of 3, 5, 10, 20, 30, 50, and 60 cc with needle sizes ranging from 18 to 27 gauge in all lengths.

Reviewed by Gary D. Vogin, MD

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