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Drug Development for an Aging Population
Fueled by unprecedented medical, technological and social advancements of the past century, it should be no surprise that we are living longer than ever before. By 2030, more than one in four people in Europe and North America will be 60 years or older. And by 2050, life expectancy at birth is projected to exceed 80 years in Europe, Latin America and the Caribbean, North America and Oceania.(1)
Yet, while research clearly shows that we are living longer, an aging population raises important considerations related to health care. In short, we know that we are living longer, but are we living better?
Evidence suggests a decrease in functional limitations and disabilities for people 85 years and younger.(2) Yet, an increase in chronic conditions has important implications for older adults. In the US, researchers estimate that 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions. This figure jumps to nearly 46 percent for adults ages 70 and 79.(3)
Polypharmacy, the concurrent use of multiple medications by a patient, increases the risk of inappropriate medication use, which can contribute to drug-induced diseases, adverse drug reactions, drug interactions, cognitive impairment, falls, hospitalization and mortality. As the population ages, polypharmacy will become more widespread.
Polypharmacy and the Opportunity for Pharmaceutical Innovation
The risks associated with polypharmacy and older adults present a new opportunity for pharmaceutical companies to identify and develop innovative solutions. Last month, Fereshteh Barei shared insights during a workshop organized by BioNowin Sante Avenue Association on how several EU-based companies have already begun work in this space.
Understanding the Key Challenges
Fereshteh’s presentation, Longevity: An Innovative Adventure, revealed a number of challenges that must be considered for geriatric pharmaceutical development:
Physiology and pathophysiology: Older adults often present hepatic or renal impairment, altered pH values in the stomach and gastro-intestinal motility, changes in body weight, loss of body fluid and more fatty tissue. Hyposalivation, xerostomia (dry mouth), impaired mastication (chewing) and dysphagia (trouble swallowing) are also more common. These changes have a substantial impact on the pharmacokinetic and pharmacodynamic profile of the drug. A lack of age-appropriate dosage forms often leads to off-label coping practices. For example, modifications like opening capsules and mixing content with food to facilitate intake or to lower the dose may be used.
Cognition: Elderly adults often suffer from reduced or gradually impaired cognition, mental capabilities and forgetfulness, which can lead to missed or incorrect doses.
Sensory functions: Impaired near visual acuity and/or overall vision can result in difficulties reading the product label or package leaflet, handling preparations or opening containers, picking tablets from the container and pushing tablets through a blister package.
Solutions to Address the Key Challenges
The presentation also offered a number of solutions to address key challenges, including:
Lower dose options to avoid challenges with splitting medication (extended release, shape and form, narrow therapeutic index, etc.) when a lower dose is recommended due to hepatic or renal impairment.
Combination products to reduce pill burden.
Age-friendly formulations such as multiarticulate pellets, ODTs, film dose and patches to improve usability.
Innovative packaging to maximize manageability and avoid administration issues.
Route of administration changes to facilitate drug intake.
Anti-aging medicines for healthy aging.
Digital health solutions to improve adherence.
Innovation is Already Underway
Several recent examples show that the global pharmaceutical industry is responding to polypharmacy challenges with an increasing number of innovative geriatric-friendly formulations that have either reached the market or are currently under development:
Eisai Ltd has marketed a geriatric-friendly oral jelly formulation of donepezil available in a number of strengths, claiming to improve swallowability.
Sensidose, a Swedish pharmaceutical company, has developed a programmable dosing device which dispenses the appropriate number of tablets to patients.
Elmed, established in 1996 as a wholly-owned subsidiary of Eisai, has been developing affordable, high-quality pharmaceuticals for elderly Japanese patients.
In the US, Azurity Pharma offers a wide range of oral solutions suitable for pediatric and elderly populations.
In Europe, Rejuvenate Biomed is working on repurposing APIs for elderly diseases.
Many innovations intended to improve medicine for older adults can be approved through the 505(b)(2) pathway in US. With the right development strategy and team, this approach offers a unique opportunity for rapid approval, low development risk and high profit potential.
Will you join the effort to provide better medicines for our aging population?
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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.