Examiner's claims are now available for Parkinson patent applications. The rejection is nearly identical to the Probuphine patent battle (the sum of known patents is equal to the new application). Titan successfully replied then explaining that the difference (and new patentable effect) is coming from the difference of the buprenophine level in plasma to achieve the same effect as sub-lingual application. HOW IRONIC!!! FDA issued CRL because of this difference! Go figure...
Titan may have a way to defend their position on Parkinson patent application (similar to Probuphine patent). If the data is available for Parkinson...
As a side note, in the Probuphine application they referenced Alan Bye, PhD study. Is this the study that maybe used for CRL?
Titan stated that CRL requested study or data that will address " The effect of higher doses of Probuphine, ideally doses more closely approximating the blood plasma levels associated with sublingual doses of buprenorphine of 12 to 16 mg / day"
Pharmacokinetic parameters of buprenorphine after the administration of 16 mg buprenorphine and naloxone sublingual tablet doses and 16 mg buprenorphine HCl sublingual tablets dose (mean [%CV]) are approx. 5.5 to 6 ng/mL.
4 Probuphine rods get between 0.5 and 1.1 ng/mL.
It is impossible to insert 20 to 40 rods!
Is this the end of the story???
Are you looking at FDA adcom downloads with "ucm351452" in the link?
Search for " DR. SKEETE: Good morning. My name is Rachel Skeete, and I'm a medical officer in the Division of Anesthesia, Analgesia, and Addiction Products." Couple of paragraphs later you will find it.
Look for the minutes of the AdCom, it's on the FDA site in word format. Page 142
This was a nice post.
Can you answer the question posted by FDA Officer during AdCom: "For the clinical pharmacology studies in the development program, the sponsor was told that at least one adequate dose-finding study should be conducted. Additionally, the doses they proposed
for the phase 3 clinical trials appeared to be too low" (page 142 of the transcript)???
Application Number: 13/525,193
IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF DOPAMINE AGONIST
08-05-2013 Response to Election / Restriction Filed (Titan selected claims)
08-07-2013 Date Forwarded to Examiner
10-21-2013 Non-Final Rejection
under application data 'Non Final Action Counted, Not Yet Mailed "
under transaction history "10-21-2013 Non-Final Rejection"