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Osteoporosis
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
Mazen Nasrallah, Marcy B. Bolster
Abaloparatide, a new anabolic agent, was FDA approved in 2017. Abaloparatide is a synthetic analogue of the PTH-related peptide (PTHrP).16 Like teriparatide, it is administered subcutaneously once daily via an auto-injector pen. The main advantage of abaloparatide over teriparatide is convenience, as the injection pen does not require refrigeration. There is also a lower incidence of associated hypercalcemia. A phase 3 clinical trial examining the efficacy of abaloparatide compared to placebo also compared abaloparatide to open-label teriparatide and showed a similar improvement in BMD and reduction in fracture risk.17
Risk of dosing errors in ART treatment: user experience of single- vs multi-use follitropin alfa pens
Published in Expert Opinion on Drug Delivery, 2021
Helen Saunders, Linda Bjärgestad Lamp, Hasan Donat, Monja Messner, Maren Reder, Helen Kendrew
The first follitropin alfa biosimilar launched in Europe was Bemfola® [2,17], developed by Finox Biotech (Switzerland), a member of the Gedeon Richter group, in collaboration with Ipsomed, a leading designer and manufacturer of pens and auto-injection systems. The product is delivered in a novel, innovative injector pen system for which it received the Red Dot Design Award in 2011, and is designed as a pre-filled, ready-to-use, single-use, disposable pen available in five different doses (75IU/0.125 ml, 150IU/0.25 ml, 225IU/0.375 ml, 300IU/0.50 ml, and 450IU/0.75 ml). It has been assessed by the EMA to have no clinically relevant difference in efficacy and safety profile compared with Gonal-f® [2,17]. Each dosage is differentiated by a different color on the dosage knob of the pen, making it easily identifiable for the user. The Bemfola® pen also allows a precise, fine-tuned dosing adjustment in 12.5IU and 25IU increments with a bi-directional dose dial. The pen is intended for self-injection by patients who have been adequately trained by a qualified healthcare professional, such as a nurse or physician.
Functionality of a novel follitropin alfa pen injector: results from human factor interactions by patients and nurses
Published in Expert Opinion on Drug Delivery, 2018
Helen Saunders, Laura de la Fuente Bitaine, Chriss Eftekhar, Colin M. Howles, Johanna Glaser, Tina Hoja, Pablo Arriagada
Bemfola (follitropin alfa) is produced using recombinant DNA technology and is a formulation of the naturally occurring hormone FSH, which plays a key role in human reproduction. The product is the result of a targeted drug development process aimed to replicate as closely as possible the reference product, Gonal-f® (Merck, Germany). The brief to the development engineers when designing the injector pen was to produce a novel, state-of-the-art delivery system which minimized the number of steps a patient needed to take when preparing the injection and to ensure that the patient and physician had maximum control and the least chance of a patient error. The result is therefore a simple, single-use, once-a-day disposable device, which allows the patient to self-inject, subcutaneously. The pen has a clearly legible selected dose, as well as a click signal after successful completion of the injection, thus avoiding dosing errors, which in turn may improve therapy compliance. Given that non-compliance to treatment represents one of the most critical obstacles in a patient’s fertility journey, the availability of easy-to-use, simple injector systems, should increase the adherence to the prescribed dosage. This in turn should lead to higher compliance and ultimately success rates among patients. Studies comparing this pen with other established fertility treatment devices have shown a high level of patient preference (over 55%) and demonstrated significantly higher ratings for example, inconspicuousness, ease of use and dose adjustment for the Bemfola pen compared to other marketed pens [22,23]
Clinical pharmacological innovation in the treatment of depression
Published in Expert Review of Clinical Pharmacology, 2023
Jeffrey M Witkin, Lalit K Golani, Jodi L Smith
MDD is a disease. As such, it is hoped that new experimental data will enable a better understanding of its pathological underpinnings to facilitate improved treatment options. Although the arresting of disease progression is a more futuristic goal, new age antidepressant researchers are already reaching for improved patient care – faster acting, more robust response and remission, and take-home therapies with gusto combined with a low burden of adverse events given that dosing is as prescribed. Predictive biomarkers for the response to these drugs, research ongoing now [18], could enable an MDD patient to carry a small diagnostic kit or sensor and a subcutaneous injector pen in their pocket as diabetic patients do now. How is that for a Brave New World?