Thank you to send this message to the FDA , senators and the FBI ! The overdose epidemic in usa kills tens of thousands of Americans each year , dozens each day ! The FDA is a criminal and corrupt administration.
Exactly, but I don't see any reasons for the FDA (individual(s)?) to change their stance as long as not doing so is beneficial to them. That is my concern. Eltp do not have enough muscles to overcome, I am afraid.
The other drugs referenced make no claim to be ABUSE DETERRENTS
More specifically, Sequests primary purposes are immediate relief of pain and an abuse deterrent. To that end, when fatty meals are introduced, not only is immediate relief compromised, Sequest also places the user at additional risk of OVER DOSING
The distinction being Sequest is an IR, which means the user is taking Sequest because pain is present
Sequest is forcing the user to make a decision: Should I suffer in pain or take more pills??
The antithesis of what the FDA wants for its first IR ADF opioid
sorry that is not correct. Lets see what the FDA said:
here is what the FDA review said:
Sept 10, 2015 FDA comments re Avridi:
• When taken with food – Absorption of oxycodone from AVRIDI is substantially delayed. • AVRIDI Tmax: Median 4h; Range 1 – 9 h. • Roxicodone Tmax: Median 1.5 h; Range 0.5 – 4 h. – Oxycodone exposure with AVRIDI is low over 4 – 6 hr compared to Roxicodone • As demonstrated by substantially lower partial AUC. – AVRIDI takes longer to achieve comparable systemic exposurecompared to Roxicodone. – Existing IR products do not show delayed Tmax to this extent.
ouch!!!! I would have thought that our A team would have realized they had an issue in Sept, 2015, but.....apparently not
Elichen- Added some info to your previous post, so well written-
Federal House Health subcommittee members need to know about the stupid FDA decision blocking implementation of this ADF.
Jurisdiction:
Public health and quarantine; hospital construction; mental health; biomedical research and development; health information technology, privacy, and cyber security; public health insurance (Medicare, Medicaid) and private health insurance; medical malpractice and medical malpractice insurance; the regulation of food, drugs, and cosmetics; drug abuse; the Department of Health and Human Services; the National Institutes of Health; the Centers for Disease Control; Indian Health Service; and all aspects of the above-referenced jurisdiction related to the Department of Homeland Security.
Investors start calling representatives and voice your displeasure with the FDA bureaucracy.
Republican Members
Joseph Pitts (Pennsylvania - 16) - Chairman Phone: (202) 225-2411 Brett Guthrie (Kentucky - 02) - Vice Chairman Phone: (202) 225-3501 Ed Whitfield (Kentucky - 01) phone: (202) 225-3115 John Shimkus (Illinois - 15) Phone: (202) 225-5271 Tim Murphy (Pennsylvania - 18) Phone: (202) 225-2301 Michael Burgess (Texas - 26) Phone: (202) 225-7772 Marsha Blackburn (Tennessee - 07) Phone: (202) 225-2811 Cathy McMorris Rodgers (Washington - 05) Phone: (202) 225-2006 Leonard Lance (New Jersey - 07) Phone: (202) 225-5361 Morgan Griffith (Virginia - 09) Phone: (202) 225-3861 Gus Bilirakis (Florida - 12) PHONE: (202) 225-5755 Billy Long (Missouri - 07) Phone: (202) 225-6536 Renee Ellmers (North Carolina - 02) Phone: (202) 225-4531 Larry Bucshon (Indiana - 08) Phone: (202) 225-4636 Susan Brooks (Indiana - 05) Phone: 202-225-2276 Chris Collins (New York - 27) Phone: 202-225-5265 Joe Barton (Texas - 06) - Chairman Emeritus Phone: (202) 225-2002 Fred Upton (Michigan - 06) - Ex Officio Phone: (269) 385-0039
Democratic Members
Gene Green (Texas - 29) - Ranking Member Phone: (202) 225-1688 Eliot Engel (New York - 16) Phone: (202) 225-2464 Lois Capps (California - 24) Phone: (202) 225-3601 Janice Schakowsky (Illinois - 09) Phone: (202) 225-2111 G. K. Butterfield (North Carolina - 01) Phone: (202) 225-3101 Kathy Castor (Florida - 14) Phone: (202) 225-3376 John Sarbanes (Maryland - 03) Phone: (202) 225-4016 Doris Matsui (California - 06) Phone: (202) 225-7163 Ben Lujan (New Mexico - 03) Ph: (202) 225-6190 Kurt Schrader (Oregon - 05) (202) 225-5711 Joseph Kennedy (Massachusetts - 04) phone: 202-225-5931 Tony Cárdenas (California - 29) phone: (202) 225-6131 Frank Pallone (New Jersey - 06) - Ex Officio Phone: (732) 249-8892
Investors start calling Senators and voice your displeasure with the FDA bureaucracy.
Senate subcommittee on health:
Chairman (R) Patrick J. Toomey (PA) Phone: (202) 224-4254
Chuck Grassley (IA) Phone: 202-224-3744 Pat Roberts (KS) Phone: 202-224-4774 Michael B. Enzi (WY) Phone: (202) 224-3424 Richard Burr (NC) (202) 224-3154 Dan Coats (IN) (202) 224-5623 Dean Heller (NV) Phone: 202-224-6244 Tim Scott (SC) Phone: (202) 224-6121
Ranking Member (D) Debbie Stabenow (MI) (202) 224-4822
Maria Cantwell (WA) Phone: (202) 224-3441 Robert Menendez (NJ) 202.224.4744 Benjamin L. Cardin (MD) Tel: (202) 224-4524 Sherrod Brown (OH) (202) 224-2315 Mark R. Warner (VA) Phone: 202-224-2023