product pipeline
Nalmefene Implant
for the prevention of relapse in OUD patients following detoxification from opioids
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Preclinical in progress
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Preclinical not started
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Preclinical not started
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Preclinical not started
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Preclinical not started
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| Preclinical | Phase 1 | Phase 2 | Phase 3 | Market |
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In September 2019, the National Institute for Drug Addiction ("NIDA") awarded Titan approximately $8.7 million in a two-year grant for its nalmefene implant development program for the prevention of opioid relapse following detoxification from opioids. This grant provides funds for the completion of implant formulation development, cGMP manufacturing and non-clinical studies required for filing an Investigation New Drug ("IND") application.
The nalmefene implant is in development as a six-month or longer (subdermal) formulation of this opioid antagonist for the prevention of relapse following opioid detoxification in adults with Opioid Use Disorder (OUD).
During the first quarter of 2020, the Company met with the U.S. Food and Drug Administration ("FDA") to review Titan's non-clinical development plans and obtain guidance regarding filing an IND.
Titan has been making good progress with the IND-enabling non-clinical studies, which it expects to complete in mid-2021, followed by filing of the IND.
The ProNeura® Long-term, Continuous Drug Delivery Platform
Titan's proprietary long-term, drug delivery platform provides continuous drug release and non-fluctuating medication levels over a period of six months or longer depending on drug characteristics. ProNeura products are subdermal implants that are intended for treating chronic diseases for which the maintenance of stable medication levels could offer advantages over other routes of administration.