Smart design of patient-centric long-acting products: from preclinical to marketed pipeline trends and opportunities

ABSTRACT

Introduction

We see a development in the field of long-acting products to serve patients with chronic diseases by providing benefits in adherence, efficacy, and safety of the treatment. This review investigates features of long-acting products on the market/pipeline to understand which drug substance (DS) and drug product (DP) characteristics likely enable a successful patient-centric, low-dosing frequency product.

Areas covered

This review evaluates marketed/pipeline long-acting products with greater than 1 week release of small molecules and peptides by oral and injectable route of administration (RoA), with particular focus on patient centricity, adherence impact, health outcomes, market trends, and the match of DS/DP technologies which lead to market success.

Expert opinion

Emerging trends are expected to change the field of long-acting products in the upcoming years by increasing capability in engineered molecules (low solubility, long half-life, high potency, etc.), directly developing DP as long-acting oral/injectable, increasing the proportion of products for local drug delivery, and a direction toward more subcutaneous, self-administered products. Among long-acting injectable products, nanosuspensions show a superiority in dose per administration and dosing interval, overwhelming the field of infectious diseases with the recently marketed products.

KEYWORDS:

• Adherence impact
• business case
• drug properties
• long-acting oral and injectables
• market trends
• patient centricity

Article highlights

• Positive impact of long-acting formulation on patient adherence, treatment outcomes, and cost for healthcare system

• Technical feasibility of long-acting injectables depends on design of suitable drug substance and product properties

• Superiority of suspension with regard to dose/administration and dosing frequency

• Trends toward increasing interest in product development for local drug delivery

• Shorten overall development times and cost through development of more engineered molecular entities

• Transition from intramuscular to subcutaneous associated with the convenience of self-administration

This box summarizes key points contained in the article.

Acknowledgments

The authors would like to thank Kuno Wuersch for his valuable expertise and support with the local tolerability section; and their colleagues (Sarah Claus, Joshua Croteau, Veronika Ehmke, Andreas Fisch, Leyana Kyritsis, Jean Quancard) for their support with final reviewing of the manuscript.

Declaration of interest

K Sedo is the employer of PharmaCircle LLC, Sunny Isles Beach, FL, USA. All other authors work for Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17425247.2022.2106213

Additional information

Funding

This paper was not funded.