Posted 16 February 2015
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is prepared to spend nearly a million dollars over the next two years to study the quality and effectiveness of long-acting generic drug products, including levonorgestrel-based birth control products, the agency announced last week.
The announcements, made on the National Institutes of Health's (NIH) website, relate to three separate study proposals focused on long-acting (LA) pharmaceutical products:
|Pharmacometric Modeling and Simulation for Long-Acting Injectable Products||RFA-FD-15-008||13 February 2015 ||28 April 2015|
|Dissolution Methods for Long-acting Periodontal Drug Products||RFA-FD-15-007||13 February 2015 ||28 April 2015|
|Dissolution Methods for Long-acting Levonorgestrel Intrauterine System||RFA-FD-15-006||13 February 2015 ||28 April 2015|
A Focus on Generics
As FDA explains in each notice, the agency's focus isn't so much on long-acting products as it is specifically on generic long-acting products.
For example, in its funding opportunity notice for Pharmacometic Modeling and Simulation for Long-Acting Injectable Products, FDA's Center for Drug Evaluation and Research (CDER) explains that the findings from the study will "help establish scientific and regulatory standards for ensuring therapeutic equivalence of generic long acting injectable (LAI) products."
As the agency goes on to explain:
The active pharmaceutical ingredient (API) in long acting injectable (LAI) products is usually encapsulated in microspheres (i.e., glycolide/lactide matrix) that extends the release of API into the systemic circulation, giving a relatively long apparent half-life and a unique PK profile. …
The current BE guidance in regards to LAIs is that the generic formulations are required to be qualitatively (Q1) and quantitatively (Q2) the same as the reference-listed drug (RLD). In general, the FDA recommends in vivo single-dose, randomized, parallel BE study in healthy volunteers. However, parallel BE studies with LAI products are very challenging due to high inter-subject variability, complex PKPD profiles, study length and expenditure.
FDA said it hopes its research will be able to "assist development of generic LAI products.” The agency plans to spend as much as $600,000 on this area of research in 2016.
Two other awards announced by FDA relate to two specific types of products: birth control implants and periodontal drugs.
As explained in two proposals, FDA believes there to be a "lack of compendial or biorelevant in vitro drug release assays for long-acting [periodontal dosage forms and contraceptive intrauterine systems]."
FDA says it plans to spend at least $250,000 on developing those methods for periodontal drugs, and at least $125,000 on developing them for intrauterine drug systems.
"The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic long-acting … drug products," FDA explained in both notices.
FDA's study on birth control devices will use Mirena as a reference product, it said.
In all award notices, FDA said future funding may also become available.