we'll be ok...
Moving forward:
Discussions with Terumo over potential injectable projects continue
The return of the TPM®/Oxymorphone patch in early 2018 (due to Japanese specific
market concerns) has promoted the co-developed TPM®/Propofol injectable to flagship position in this relationship. The development of a TPM®/Propofol injection had unique challenges – none less thanthe need for the formulation to support acute injection as well as 24hr infusion.
This is the first timethat this TPM® based injectable formulation (or in fact TPM® alone) will be tested at such high doseover such a long exposure period in formal toxicology studies. Formulation design and agreement onthe exact test protocols have lengthened the program and extended the toxicology program timeline.
However, we believe that a suitable program is now designed and the testing pathway can now continue.
Ensuring the right toxicological program for TPM®/Propofol injectable formulation is important as itpotentially has wide reaching implications for all of the TPM® injectable program. It is expected thatpositive results will provide data that can support and potentially reduce the toxicological testingrequirements of all future TPM® injectables. We also believe that these results will play a role in the
direction that Terumo decides to take.....
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