Orazol™ - Improving the 'Standard of Care' in Bone Metastases
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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:
Ph II efficacy data showed pharmacodynamic equivalence
Orazol™ showed more rapid and greater magnitude of pain relief in cancer patients with bone metastasis
Orazol™ Press Releases
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 |