SCOLR drug delivery tech clears clinical hurdle
pseudoephedrine developed by drug delivery company SCOLR Pharma has
successfully cleared a clinical trial, providing a validation of
the firm's technology platform, reports Phil Taylor.
SCOLR, like a number of its peers in the drug delivery sector, is using its formulation platform to develop new versions of generic drugs that offer improved functionality and a competitive edge in the marketplace.
The aim is to reduce reliance on the pharmaceutical sector, the traditional partners of drug delivery companies that have tended to use their services to extend the patent lives of their product franchises by launching products with improved dosing. This has involved little risk for the drug delivery company, but also a much lower financial return, generally in the form of royalties on sales.
But with the pharma sector being hit by slowing new product introductions and the loss of patent protection on a raft of big selling drugs - and the pace of growth in the market for generics - many drug delivery companies are developing their own in-house generic products.
SCOLR is just one of many drug delivery companies marching towards this more fully-integrated pharmaceutical company (FIPCO) model, which can involve either self-marketing products or licensing them out at a latter stage of development when the risk of failue is lower and licensing/royalty levels can be negotiated at a higher level. Other notable examples include Alza with Concerta and Shire Pharmaceuticals' Adderal XR, both extended-release formulations of methylphenidate used to treat attention deficit hyperactivity disorder (ADHD).
In the latest development, SCOLR has said that it achieved positive initial clinical results from the testing of its 12-hour formulation of pseudoephedrine tablets, based on its patented Controlled Delivery Technology (CDT).
The preliminary CDT pseudoephedrine human study included 24 participants, split into two crossover groups in fed versus fasted conditions. The company compared the plasma levels of the 12-hour CDT-based tablets with levels obtained from currently marketed 12-hour extended release tablets, and found that the CDT formulation provided plasma levels that were well within the acceptable range of the levels for the currently marketed products.
This is the first of three planned subject dosing studies that SCOLR Pharma is conducting in support of an Abbreviated New Drug Application (ANDA) - the regulatory route for generic drugs in the US - for a CDT-based 12-hour extended release pseudoephedrine formulation.
Stephen Turner, SCOLR's chief technology officer, said: "Our 12-hour CDT pseudoephedrine tablets are approximately one third of the size of the currently-approved similar OTC products, yet are designed to deliver an equivalent 120 milligram dose of pseudoephedrine."
SCOLR started human studies on a 12-hour CDT formulation of the painkiller ibuprofen - also manufactured by UPM Pharma - in September. The firm is also working on CDT versions of tramadol (an analgesic) and niacin (vitamin B3). Together, existing formulations of its four lead compounds currently generate $3.5 billion (€2.9bn) in annual sales.
"This study provides the basis for a larger scale study needed for US regulatory approval," said Turner. Due to the positive results from this first group of subjects, he said the company does not plan to make any changes to the CDT-based tablets or the trial design before commencing the next two study segments.
The CDT-based pseudoephedrine tablets used in the initial study were cGMP manufactured by UPM Pharmaceuticals, which is also responsible for manufacturing the remaining clinical materials to support the ANDA filing later this year.
SCOLR's CDT platform is in fact three separate technologies. The first is a so-called 'dual polymer' format, developed specifically for the controlled release of highly soluble active ingredients, such as propranolol, diltiazem, verapamil, theophylline and metformin.
The second relies on a phenomenon called 'salting out' to liberate an active drug alongside electrolytes from a polymer matrix. The primary benefit of this approach is its low production costs compared to rival technologies, such as complex osmotic pump or multi-layer tablets.
Finally, SCOLR has an amino acid platform, designed to improve the solubility of hydrophobic (poorly-soluble) drugs. This is based on a matrix containing a granulated active ingredient, ionic resins or gums, and amino acids. Upon hydration the hydrophobic drug reacts with the amino acids to form weak complexes that are more soluble and can leach out of the matrix.
