FDA funds computer simulations to goose long-acting generics

Computational drug delivery specialist Qrono has just been awarded a $612,000 FDA contract to design and deploy physiologically based pharmacokinetic (PK) models of long-acting injectables, in a bid to speed up the development of generics.

Pittsburgh's Qrono says that even though long-acting injectables have been approved since the early 1990s, there are no generics on the market due to the challenge of proving bioequivalence.

In an application for the award issued in February, the FDA explained that the long-acting injectables typically rely on encapsulation of the active ingredient in microspheres to achieving extended release of the main ingredient into systematic circulation.

"The PK profile of these products usually consists of an initial release phase where APIs on the surface of the formulation ingredients are absorbed systemically, a lag phase with minimal API release, and a main release phase in which the ingredients in the formulation degrade allowing the API to be absorbed into the systemic circulation completely," the FDA wrote.

QronoMetrics' software is designed to predict the release performance of polylactic-co-glycolic acid microparticles over 6 months or more. The company touts the simulation-based approach's simplicity as compared to standard experimental methods, which can be complex and time-consuming, accounting for the lack of generics on the market.

The computer simulations enable Qrono to select optimally designed formulations that balance bioequivalence and manufacturability for further testing in experimental validation studies, according to the company website. The company boasts a long pipeline of long-acting generic candidates.  

According to a release, Qrono plans to use the funding to study Johnson & Johnson's ($JNJ) Risperdal Consta for bipolar I disorder and Novartis' ($NVS) Sandostatin LAR for acromegaly as model drug products.    

"It is beneficial for pharmaceutical and regulatory scientists to have a method that can assess the impact of formulation composition of LAI products on their drug release and clinical pharmacokinetic profiles in a more timely and cost-effective way than the standard experimental approach," said Qrono CEO Larry Zana in a statement. "The long term goal of this project is to establish product development methods for long acting, complex drug products that will facilitate the production and regulatory approval of generic LAIs for patients in need of efficacious and cost-effective solutions to adherence and drug delivery challenges."

The FDA said in the funding application that the project "will help establish scientific and regulatory standards for assuring therapeutic equivalence of generic LAI products."

The funding comes as the feds are applying more scrutiny to the Big Pharma pricing model following outcry over big price increases by companies like Valeant ($VRX) and Martin Shkreli's Turing Pharmaceuticals.

The Regulatory Affairs Professionals Society points out that in February the FDA also sent out applications to fund research into long-acting generic forms of birth control and periodontal drugs.

- read the release
- here's the funding opportunity announcement from the FDA