Skip navigation
HomeLink
Skip navigation

Orazol™ - Improving the 'Standard of Care' in Bone Metastases

Orazol's weekly oral administration methods

Orazol™ is a weekly oral Zoledronic Acid tablet in phase III development for the treatment of metastatic bone disease.

Developed using Merrion's GIPET® technology, Orazol is a weekly oral tablet dosage, with greatly increased bioavailability, of the market leading I.V. bisphosphonate for bone metastases.

Due to poor bioavailability, the market leading bisphosphonate is currently administered by monthly intravenous infusion. The sales of Zoledronic Acid as an IV infusion were $2.0Bn in 2010.

In Phase II trials Orazol demonstrated several benefits over the current infusion therapy including:

  • Orazol tablet taken weekly had equal efficacy after one week compared with the monthly infusion as measured by standard bone turnover biomarkers (u-NTx, CTX)
  • Improved efficacy for bone pain
  • Improved safety and tolerability profile - Acute Phase Reaction was not observed with weekly Orazol treatment.

In addition to clinical advantages, Orazol offers significant benefits in patient quality of life, patient access, health economics and market expansion opportunities.

Orazol Phase II data demonstrated:

Orazol Phase II Data

Ph II efficacy data showed pharmacodynamic equivalence

Brief Pain Inventory

Orazol™ showed more rapid and greater magnitude of pain relief in cancer patients with bone metastasis

Orazol™ Press Releases

November 2010 Merrion finalises its Phase III development program for Orazol™ in the USA
May 2010 Merrion Pharmaceuticals is issued a key US patent for Orazol™
March 2010 Merrion Pharmaceuticals plc announces issuance of key United States Patent

Orazol™ Scientific Literature & Poster Presentations

Orazol™ (MER-101) Poster Presentation Safety Profile of Zoledronic Acid in a Novel Formulation - Presented at AACR-NCI-EORTC Molecular Targets & Cancer Therapeutics Conference, Boston, Nov 2009
Orazol™ (MER-101) Poster Presentation Studies of Bioavailability & Food Effect of MER-101 Zoledronic Acid Tablets - Presented at ASCO Breast Cancer Symposium, San Francisco Oct 2009
Orazol™ (MER-101) Poster Presentation final Phase II Study - Presented at ASCO, American Society of Clinical Oncology Annual Meeting May 2009
Orazol™ (MER-101) Poster Presentation - Presented at the AAPS November 2007

 

< back