| 1999 | Start of OLANI development |
| The OLANI project was started. Early R&D development to establish release rate characteristics in vitro. |
| 2000 | Early animal trials |
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R&D 001: In-vivo release of naltrexone from biodegradable depot systems. Study to evaluate the preparation of NTX Poly-(DL-Lactic) microspheres to evaluate in vitro and in vivo release characteristics in the RAT |
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| First use in humans | |
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The first clinical use of the OLANI in humans occurred under the Special Access Scheme (SAS) in Australia. This allows the use of unregistered drugs for the treatment of patients determined to be at high risk of premature death and able to provide informed consent. The early use of the OLANI has been reported in the following publications: Hulse, G. K. & O’Neill, G. A possible role for implantable naltrexone in the management of the high-risk pregnant heroin user. Aust. N. Z. J. Obstet. Gynaecol. 42, 93–4 (2002). http://www.ncbi.nlm.nih.gov/pubmed/11926651 Hulse, G. K., Arnold-Reed, D. E., O’Neil, G. & Hansson, R. C. Naltrexone implant and blood naltrexone levels over pregnancy. Aust. N. Z. J. Obstet. Gynaecol. 43, 386–8 (2003). http://www.ncbi.nlm.nih.gov/pubmed/14717319 Hulse, G. K., O’Neil, G., Hatton, M. & Paech, M. J. Use of oral and implantable naltrexone in the management of the opioid impaired physician. Anaesth. Intensive Care 31, 196–201 (2003). http://www.ncbi.nlm.nih.gov/pubmed/12712786 Hulse, G. K., O’Neil, G. & Arnold-Reed, D. E. Management of an opioid-impaired anaesthetist by implantable naltrexone. J. Subst. Use 9, 86–90 (2004). http://www.tandfonline.com/doi/abs/10.1080/14659890410001665087 |
| 2005 | TGA GMP Annex 13 license |
| Go Medical received TGA GMP Annex 13 license statues for the manufacture of investigational medicinal products |
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2006 |
GM001: Safety And Pharmacokinetics Of Implantable Naltrexone In Sheep |
| A study in to evaluate the pharmacokinetic properties and release profile of the OLANI at both the therapeutic dose and with a safety margin of ten times that therapeutic dose. | |
| GM002: Safety Of Naltrexone Poly-(DL-Lactide) Implants In Rats | |
| A study to evaluate the local and systemic safety of the OLANI at approximately ten times the therapeutic dose in the Rat. | |
| GM009: A Phase I, Single Arm, Open Label, Pharmacokinetic Trial | |
| A Phase 1, trial looking at the pharmacokinetic properties of the OLANI in the management of illicit opioid dependent persons over 6 months. | |
| GM008: A Randomised Double-Blind Placebo Controlled Clinical Trial Of The Efficacy Of An Australian Naltrexone Implant Compared To Oral Naltrexone For The Long-Term Management Of Heroin Dependent Persons. | |
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The aim of the study was to provide rigorous clinical data through a randomised double-blind placebo controlled clinical trial on the efficacy of the OLANI compared to oral NTX for the long term management of heroin dependent persons. To date 2 publications from this study have been produced Hulse, G. K., Morris, N., Arnold-Reed, D. & Tait, R. J. Improving clinical outcomes in treating heroin dependence: randomized, controlled trial of oral or implant naltrexone. Arch. Gen. Psychiatry 66, 1108–15 (2009). http://archpsyc.jamanetwork.com/article.aspx?articleid=210360 Hulse, G. K., Ngo, H. T. T. & Tait, R. J. Risk factors for craving and relapse in heroin users treated with oral or implant naltrexone. Biol. Psychiatry 68, 296–302 (2010). http://www.ncbi.nlm.nih.gov/pubmed/20537615 |
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| NCT 00521157: Naltrexone Implants After In-Patient Treatment For Opioid Dependence: Randomised Control Trial | |
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The purpose of this clinical trial was to study the efficacy and safety of NTX implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Kunøe, N. et al. Naltrexone implants after in-patient treatment for opioid dependence : randomised controlled trial. Br. J. Psychiatry 194, 541–546 (2009). |
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2009 |
Development of 2nd generation OLANI |
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The 2nd generation OLANI was developed due to changes in manufacturing techniques that allowed the upscaling of the product from R&D manufacturing techniques to commercial GMP techniques. The drug loading was also increased by 50% to extend the expected release rate profile of the implant. |
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| Full GMP license | |
| Go Medical received Full GMP statues for the manufacture of the OLANI |
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2015 |
Commencement of manufacture in new commercial GMP facility |
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A new commercial GMP manufacturing facility was completed ready for the initially batches of OLANI for validation. |