Replies to post #238698 on Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf

[WeeZuhl]

jour, the terminology is fuzzy


The phrase "oral abuse" is commonly used to refer to chewing and also commonly used to refer to swallowing extra whole pills. There is no official nomenclature at this point. It creates a lot of confusion because those are obviously separate components of abuse deterrent technology. I wish FDA and company literature would use more specific language, such as "chewing" and "overdose."

ELTP 2 bead antagonist ADF tech will easily qualify for IV, snorting, and chewing ADF label for every opioid agonist with any time-release characteristic. No known company is within 10 years of marketing an effective overdose ADF.

[mrwrn2010]

Troxyca ER was approved for all 3 labeling routes. Very similar tech to Elite's.

"TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of TROXYCA ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling."

"The abuse-deterrent features of TROXYCA ER were demonstrated in a battery of in vitro laboratory studies and three clinical abuse-potential studies utilizing crushed TROXYCA ER by oral and intranasal routes of administration and the IV route (with simulated TROXYCA ER)."

http://www.pfizer.com/news/press-release/press-release-detail/fda_approves_troxyca_er_oxycodone_hydrochloride_and_naltrexone_hydrochloride_extended_release_capsules_cii_with_abuse_deterrent_properties_for_the_management_of_pain