Javelin Pharmaceuticals Inc (JAV)

[Bio_pete]

<<<<Any thoughts on future FDA caution on safety hold-ups for intranasal PM-150 or intranasal rylomine.>>>

I don't think YMI's problems will come up with PMI-150 or intranasal morphine.

#1. PMI-150's initial indication is for emergency situations so respiratory complications in the post-op setting are not applicable. In addition ketamine is normally not associated with respiratory depression.

Ketamine has gotten a bad rap due to reports of long-lasting psychological effects from single anesthetic doses. It doesn't appear that this type of problem is seen with low dose ketamine, but it will be interesting to see if the FDA has any concerns with using ketamine for pain management.

#2.Intra-nasal morphine, Single dose nasal spray. The dosage is controlled, the nasal mucosa has a maximum saturable level, and it uses JAV's chisys technology. Rylomine reaches peak levels in 20 minutes which also improves its safety profile. A dosage in one person achieves the same blood level or within statistically acceptable levels as another person so its predictable.

The safety risks with Rylomine shouldn't result in any additional concerns seen when administering IV morphine. Its very predictable, but if you give to much morphine by IV, IM, or to much rylomine then your going to encounter adverse events.