Xalieve(TM) Gains Momentum as Calabar AB Launches a Phase II Repeated Dose Study in Dry Mouth Patients
Göteborg - Sweden 2008-10-02
Calabar AB announced today that their Phase II repeated dose study in xerostomia ("dry mouth") patients has been initiated. Specifically, the drug will be studied in 45 dry mouth patients between the ages of 20 to 75. The objective of the study is to select a dose for evaluation in a succeeding Phase III efficacy study.
Xalieve(TM) is a gel containing the cholinesterase inhibitor physostigmine. It is administered locally in the mouth where physostigmine diffuses through the mucosa reaching the minor glands. By inhibiting cholinesterase, acetylcholine accumulates and the elevated concentrations stimulate the muscarinic receptors in the minor glands, improving saliva production. Unlike systemically administered drugs, the local route of administration limits adverse events.
"Xalieve(TM) offers a completely new approach in treating dry mouth and we are very excited about this Phase II study," said Mr. Fredrik Röök, VP Business Development of Calabar. "Xerostomia is not getting the attention it deserves. These patients are experiencing dramatic decrease in quality of life, such as difficulty in swallowing and speaking, and a burning sensation in the mouth. Xalieve(TM) has the possibility to radically improve the life of millions of people suffering from dry mouth."
About Calabar AB:
Calabar is a privately-held company committed to developing pharmaceutical products addressing the significant unmet needs of xerostomia "dry mouth". The company's product Xalieve(TM) is a locally administered formulation of the cholinesterase inhibitor physostigmine, which has been shown to effectively increase salivary flow. The company is part of the Karolinska Development AB portfolio.
For more information, please visit www.calabar.se
VP Business Development
+46 8 524 860 38