Tramadol PM - Pain Management
Tramadol PM is a novel formulation of a centrally acting pain reliever indicated for the treatment of moderate to severe pain.To date we have developed a novel once daily formulation of tramadol and completed a Phase I pilot Pharmacokinetic study. Based on the positive outcome of this study we will commence Phase II clinical development expeditiously. The US registration strategy for Tramadol PM is anticipated to be based on a 505(b)(2) NDA filing which may provide a shorter development and regulatory approval pathway compared with a full NDA.
The Tramadol PM product formulation is designed for night time (PM) dosing with an initial lag in drug absorption with onset of action targeted to the morning, providing coverage for the waking/daytime hours and allowing for a drug free period during sleep when coverage is least required.
This product provides significant benefits over existing products for certain pain management situations:
- limits the risk of tolerance developing,
- limits the risk of sleep disturbance,
- minimises the likelihood of rebound on ceasing drug therapy, and
- ensures optimal pain management by ensuring therapeutic drug levels are achieved and maintained only when required.
- Minimises the risk of patients waking up in pain needing to take a medication and then waiting for pain relief to commence
- Provides extended pain relief through-out the day
- Minimises the amount of drug on board when not needed at night time
- Capsule formulation suitable for sprinkling on food.