Addressing diabesity with pen injector platforms

Cécile Gross, Global Category Manager, Parenteral, and Mark Tunkel, Global Category Director, Services, discuss the variety of pen injector platforms to meet the different needs of diabetes patients

Not a day goes by without reading in the newspapers an article on diabetes or obesity. A new word has also recently appeared: diabesity. It actually dates back to the 1970s when Ethan Sims originally used the term to describe studies in which healthy prisoners were deliberately overfed to gain weight and become overweight, but not obese. The aim was to demonstrate reversible rises in fasting glucose and a deterioration of glucose tolerance, not diabetes. The former American Diabetes Association President Francine Kaufman, amongst others, has used this term since then to describe the co existence of the twin pandemics – and the term spread. Exactly like the obesity pandemic itself. In 2022, the WHO estimated that one in eight people are living with obesity,1,2 showing a huge increase in adults and a massive increase in teenagers, which led to the acceleration of the WHO’s plan3 to stop it. This has been substantiated by a new study released by The Lancet4 – stating that more than 1 billion people in the world are living with obesity.
Diabetes is a worldwide health problem, and combining this condition with underweight or obesity adds to the burden on patients even more. This reflects the intricate relationship between complex chronic diseases and their snowball effects in today’s world.

ARE ALL PATIENTS THE SAME?

Looking at available treatments for diabetes, insulin has been known and used for more than 100 years and, more recently, peptides such as glucagon-like peptide 1 (GLP-1) have also been used. Since the first US FDA-approved GLP-1 in 2009, pharma companies have worked to reduce injection frequency, improve the drug delivery device and even offer diverse administration routes, such as oral delivery. Although limited to Type 2 diabetes, they offer patients the possibility of having less-frequent injections. Obesity patients can now benefit from them as an alternative to bariatric surgery.
However, patients cannot be considered as one homogenous group: there is a discrepancy in incidence between women and men, adults and teenagers, and geography is also adding to the complexity
of care. As an example, healthcare systems, buying powers and cultural habits differ between the US, Europe and India and will lead to differentiated offerings to meet patients’ needs. As a drug delivery device manufacturer and combination product service provider, Nemera’s responsibility is to consider these characteristics and implement them into its devices.
US patients, for example, usually performunit-dose injection with a disposable device. Given the relatively high volume per dose to be injected, it implies a spring-assisted injection. European patients still need to perform a high-volume injection, but they will use either a unit-dose or a multiple-dose disposable delivery device. In both cases, injection is spring assisted. Indian patients are very sensitive to cost per injection; therefore, they would rather use a multiple dose delivery device. Mostly they opt to use reusable devices as they are much more cost effective, whilst some others may still prefer to use manual disposable ones.

PEN INJECTOR PLATFORMS TO MEET DIFFERENT NEEDS

PenSET and PenDIA
The PenSET and PenDIA platforms can accommodate GLP-1 drugs with a smooth spring-assisted injection. A multiple-dose device has been chosen rather than a unit-dose one to alleviate the burden on the patient. Having one month’s treatment available in one single device instead of four separate devices makes it less cumbersome, eases portability when travelling or going to work and fosters acquaintance with the device through longer use of the same device. The risk of dosing errors is also reduced as there is no possibility of overdosing during the four week period as the dose to be administered comes into the same device, not a separate one. The reason why these two platforms coexist is to address the need for a fixed dose on one hand and a variable dose with dose correction on the other. In both cases, the result is fewer discarded devices in the end.

PENDURA AD
PENDURA AD  is also a multiple-dose and spring-assisted platform; however, it is not disposable but reusable for three years. When patients finish using the drug in the cartridge, they just have to replace it with a new one. On top of being cost effective and offering a seamless injection, the device has several features to give patients a cue of injection dose completion: clear visibility of the drug, marking on the cartridge holder and a green dot once the device goes back to its initial position. With a track record of more than 10 years in several markets, this platform has been selected by Nemera’s Danish partner Zealand Pharma. It is offering dasiglucagon, a next-generation ready-to-use glucagon analogue. Dasiglucagon is being developed for several therapies. Thanks to a constructive co-operation between the two companies, the PENDURA AD platform has been chosen to deliver dasiglucagon, and the benefits of this combination are being investigated in clinical trials.
On the topic of clinical trials, an integrated connected pen is also available. Customised from Nemera’s reusable pen platform PENDURA AD, it features a Bluetooth module integrated into the pen itself, which can help transfer data to an app. Before transferring it, the data related to the injected dose are displayed on the screen, together with the date and time of injection. Complete data are available in the history on the application.

PENVARIO
Nemera chose to develop a pen platform versatile enough to deliver the abovementioned drugs, as well as others. PENVARIO (Figure 4) is a manual pen platform able to address diabetes and obesity with rapid-acting or long-acting insulins and GLP-1, osteoporosis with parathyroid hormones, such as abaloparatide, and fertility with folliclestimulating hormones, such as follitropin alpha. Each variant of the platform has been designed to match the specificities of the different target populations and regimens.
Returning to the example of India, where the prevalence of diabetes is very high, a multidose, disposable manual pen makes the treatment affordable at a low pricing point. It also offers the same patient injection experience as the conventional insulin pen injector. Another area of interest is to help keep track of the number of doses injected. When the treatment becomes regular, patients have difficulty following up their regimen. In addition, within the ageing population, a lot of people take more than one treatment frequently, so having to remember if they have taken their dose could be tricky. To avoid underdosing or overdosing, Nemera’s pen injectors can be customised with a specialised add-on. Designed to assist patients in monitoring their injections, it collects details on injected doses and adds them into a history. The aim is to accurately count the administered number of doses by recognising key parameters such as typical pen-use sequences, pen position and the distinctive injection-dose signature, while detecting each specific step of priming and injection

To read the full article: 160_2024_May_Injectables_Nemera
To read the full magazine: Injectables-ONdD-May-2024-Issue-160-MedRes

About Nemera

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