Development of Age-appropriate Formulations and Doses for Elderly Patients Could Enable Smarter Prescription of Approved Drugs, says GBI Research
Despite the elderly being the fastest-growing segment of the global population, only a few of their treatments have been clinically trialed in age-appropriate patients
Despite the elderly being the fastest-growing segment of the global population, only a few of their treatments have been clinically trialed in age-appropriate patients, with many of their therapies still not available in suitable formulations and dosages, says business intelligence provider GBI Research.
According to the company’s latest report*, many older people suffer from comorbid conditions and one in three takes at least five drugs or more on a daily basis. This significantly increases the risk of Adverse Drug Events and hospitalization, with up to one third of elderly emergency admissions being drug-related.
GBI Research states that off-label prescriptions are common for older patients, as pre-marketing drug trials often exclude geriatric patients and approved doses are not likely to be appropriate for the elderly.
Antipsychotic medications, for example, are regularly prescribed off-label in up to 80% of care-home patients, to manage delirium, agitation and psychosis resulting from Alzheimer’s disease and schizophrenia. However, these drugs have been associated with an increased risk of diabetes, cerebrovascular events and death, according to the report.
In 2010, the International Conference on Harmonisation (ICH) updated its E7 guidelines, which determined that the number of older patients should be representative of the study population and not limited to 100 patients, as previously indicated. Additionally, ICH E7 recommended that people aged 75 years and older should be incorporated in clinical trials, including those with comorbidities using concomitant therapies.
GBI Research believes that the development of age-appropriate formulations and doses could allow for smarter prescriptions of approved drugs, such as anti-coagulants, anti-diabetic agents, antipsychotics and analgesics in older people. Additionally, new opportunities exist for companies to develop medicines for age-related diseases, including cognitive impairment, sarcopenia and neurodegenerative diseases.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
