Rexista shouldn't be less abuse-resistant than existing drugs. FDA looks at commercially available oxycodone ER drugs. So if Rexista is only going for IV (intravenous) labeling at the PDUFA, I would guess FDA would issue a CRL (Complete Response Letter), since existing drugs deter more than one abuse pathway. If FDA were to give approval, Rexista would be less abuse-resistant than existing drugs.
Remoxy has filed 3 times and issued 3 CRL letters. Remoxy failed the nasal labeling, but I would guess Remoxy satisfied the IV labeling. Remoxy abuse studies for nasal used animals instead of humans. So FDA is requiring humans be used for Remoxy's nasal abuse studies. It is called "Human Abuse Potential". Looks like FDA was not too keen on Remoxy substituting animals for humans. This was back in February 2017, when FDA gave guidance on what was required of Remoxy after the CRL was issued. What a blunder the company developing Remoxy made by using animals. Did the company even ask the FDA that they could use animals?
IPCI should have recognized Remoxy's situation back in Feb 2017. IPCI is in a similar situation and is now planning to do a nasal HAP study after hearing the Adcomm. IPCI better be using humans and not using animals like Remoxy did for their study. FDA seems to be requiring Remoxy to satisfy many abuse pathways before giving approval. So I would guess FDA will require Rexista satisfy many abuse pathways before giving it approval.
Market Data 
Markets 
AI
