‘Patient-Controlled’ Injector Approved for Tremfya

The drug-delivery device performed well in a patient study.

Image of the Tremfya One-Press courtesy of Janssen Pharmaceutical Companies of Johnson & Johnson

Patients now have another option for injecting Tremfya—a drug-delivery device designed specifically for patients. FDA has approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. TREMFYA is given as a 100-mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4, Janssen Pharmaceutical Companies of Johnson & Johnson reported. Tremfya One-Press may be used by patients for self-injection with doctor approval and proper training, it was reported. West Pharmaceutical Services Inc. supplied the device.

One-Press could ease the patient experience. “Janssen understands that patients living with plaque psoriasis may struggle with self-administering treatments due to a number of factors, including needle phobia,” Megan Farina, Janssen Immunology Communications, told MD+DI. “One-Press was designed with patients in mind: it fits comfortably in the hand and offers a controlled injection that hides the needle throughout the process. A soft click indicates when administration is complete resulting in nearly 99 percent of patients reporting a successful first injection, and after three injections, patients still reported favorable outcomes with the usability of the One-Press device.” One-Press also includes a safety system that protects the needle after use, she said.

The device performed well during a patient study. In the Phase 3, multicenter, randomized ORION study, patients shared feedback on injections, self-image, self-confidence, pain and skin reactions during or after the injection, ease of use of the self-injection device, and satisfaction with self-injection. The mean score for “Satisfaction with Self Injection” was 9.18 (with 10 indicating “Very Satisfied”) and the mean score for “Ease of Use” was 9.24 (with 10 indicating “Very Easy”), Janssen reported in the news release.

“The results of the ORION study showed the administration of Tremfya with One-Press was safe and effective, providing patients with a new, more convenient way to inject their treatment,” stated Laura Ferris, M.D., Ph.D., Associate Professor, Department of Dermatology, University of Pittsburgh Medical Center, in the release. “These findings are also exciting as they demonstrated that treatment with TREMFYA helped half the patients achieve complete clearance with a PASI 100 response at week 16.”

“Patients living with plaque psoriasis often struggle with a conventional syringe when administering treatment,” added Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “With the approval of One-Press, patients now have the option to self-administer TREMFYA with a novel device that is both simple and intuitive to use.”

Patients will still have two options for Tremfya, a prefilled syringe and the One-Press device, Farina told MD+DI.

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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