In the Pipeline
The table below summarizes the development status of AMITIZA, Rescula and several other prostone-based product candidates. We currently hold all of the commercialization rights to the prostone compounds in our product pipeline, other than for commercialization of AMITIZA in the U.S., Canada and Japan, which is covered by our collaboration and license agreements with Takeda and Abbott, and for Rescula, for which we hold the U.S. and Canadian rights. Commercialization may be several years after successful completion of studies.
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Target Indication | Development Phase | Next Milestone | ||||
| AMITIZA® (lubiprostone) | |
Chronic idiopathic constipation (CIC) (adults of all ages) | Marketed in the U.S. | ― | ||||
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Approved in Switzerland | Pricing negotiations with Swiss government health agency | ||||||
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| Phase 3 efficacy and safety trials in Japanese patients results reported | Approval of marketing authorization in Japan | |||||||
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| Irritable bowel syndrome with constipation (adult women) (IBS-C) | Marketed in the U.S. | ― | ||||||
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| Chronic idiopathic constipation (CIC) (pediatric patients with renal impairment and patients with hepatic impairment) | Phase 4 pediatric, renal impairment and hepatic impairment trials completed and submitted to the FDA | ― | ||||||
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| Opioid-induced bowel dysfunction (OBD) | Two phase 3 efficacy trials completed reported | Phase 3 safety trial and the third efficacy trial to complete in 2011 | ||||||
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| Product/Product Candidate | |
Target Indication | Development Phase | Next Milestone | ||||
| Rescula (unoprostone) | |
Dry age-related macular degeneration (dry AMD) |
Preclinical |
Phase 2a trial |
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Glaucoma and ocular hypertension | Approved in the U.S. | Limited commercialization | |||||
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| Product/Product Candidate | |
Target Indication | Development Phase | Next Milestone | ||||
| Cobiprostone | |
Gastrointestinal |
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Prevention of non-steroidal anti-inflammatory drug (NSAID)- induced ulcers | Phase 2a trial results reported | Phase 2b trial | |||||
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| Oral mucositis | Preclinical | Phase 1 trial | ||||||
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| Pulmonary |
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| Chronic obstructive pulmonary disease (COPD) | Preclinical | Finalize inhaled formulation | ||||||
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| Product/Product Candidate | |
Target Indication | Development Phase | Next Milestone | ||||
| SPI-3608 | |
Spinal stenosis | Preclinical | Phase 1 trial | ||||
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As of March 25, 2010