Innovation that Creates Options
Nesvik Pharmaceuticals became a division of BioStem Technologies in 2018, but our veteran pharmaceutical development team has been preparing for the important work we’re doing for decades. With the right combination of business, regulatory, clinical, and R&D expertise, we’re well-equipped to successfully navigate the path from idea, to development, to trials, to approval.
Drug reformulation isn’t an empty bid for business—it’s a way to advance patient care. That’s why the FDA has rightfully allocated a special path to approval for reformulation: 505(b)(2). As more physicians realize the significance of a high pill burden, the prevalence of pill aversion, and the adverse effects of patient noncompliance in both acute and chronic conditions, having additional options available for patients will be crucial. We believe dosage form shouldn’t derail treatment. It’s what we’re working towards every day.
The Consequences of Pill Dysphagia
And Elderly patients are disproportionately affected:
Prevalence of dysphagia in patients over 65 years of age: 7-13%2
Dysphagia reported in about 50% of patients in nursing facilities2
What can fix this problem?
Limiting or excluding solid dosage forms—which is only possible when APIs are available in other formulations.2
References: 1. Fields J, Go JT, Schulze KS. Pill Properties that Cause Dysphagia and Treatment Failure. Curr Ther Res Clin Exp. 2015; 77: 79-82. 2. Logrippo S, Ricci G, Sestili M, Cespi M, Ferrara L, Palmieri GF, et al. Oral drug therapy in elderly with dysphagia: between a rock and a hard place! Clin Interv Aging. 2017; 12: 241-51.