News
SCOLR Announces Completion of 12 hour CDT-Pseudoephedrine ANDA Registration Batches, New Drug Development Targets
SCOLR Pharma, Inc. (Amex: DDD) announced today that its contract manufacturing partner, Cardinal Healthcare, has produced batches of SCOLR's 12 hour CDT-based pseudoephedrine tablets needed for the completion of its Abbreviated New Drug Application (ANDA) scheduled for submission later this year.
At the same time the Company announced that it has commenced development of initial once-daily risperidone and rivastigmine formulations using its Controlled Delivery Technology (CDT(R)) oral drug delivery platform.
Stephen Turner, SCOLR's Chief Technical Officer, said, "The manufacturing of our 12 hour CDT-based pseudoephedrine registration batches is an important step for completing the documentation for our first ANDA submission later this year. We have already concluded clinical testing to support that our novel CDT-based pseudoephedrine tablets, which are only 1/3 the size of the currently-marketed tablets, are bioequivalent to them."
He also said: "Our formulations of both risperidone and rivastigmine represent significant potential future products candidates for our development portfolio. Further, this work is intended to further demonstrate the utility of our CDT oral drug delivery technology over a broad spectrum of therapeutic categories."
In addition to its four marketed once daily nutritional products, SCOLR has completed 14 clinical trials including more than 400 subjects for analgesic, cardiovascular, cough-cold, anti-nausea, and osteoporosis CDT-based tablet formulations. The Company is preparing to begin testing of initial immediate release CDT-based fenofibrate formulations in the near future and plan to start testing its initial once-daily CDT-based risperadone and revastigmine formulations in late 2007/early 2008.
Risperidone is the active ingredient in Risperdal(R), Janssen, L.P.'s product for the management of schizophrenia and bipolar mania. In 2005, Janssen reported U.S. 12 hour sustained release Resperdal(R) sales of more than $1.5 billion.
Rivastigmine is the active ingredient in Excelon(R), Novartis's product for the management of Alzheimer's disease. In 2006, Novartis reported global 12 hour sustained release Excelon(R) sales were approximately $500 million.
Pseudoephedrine is an active ingredient in Allegra(R) D, 12 hour Sudafed(R) PSE, 12 hour Claritin(R) D, Zyrtec(R) D and other OTC and prescription products for upper respiratory discomfort. The domestic OTC decongestant market for pseudoephedrine-containing products is estimated to exceed $1 billion annually.
Fenofibrate is the active ingredient in Tricor(R), Abbott's product for total cholesterol management. In 2005, Abbott reported Tricor(R) global sales of $800 million.