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New article on seeking alpha by Kempharm long.
http://seekingalpha.com/article/3978737-upcoming-shifts-abuse-deterrent-opioid-market-size-potential-upside-kempharm-small-biotechs
It's all about the label.
This article incorrectly refers to Pfizer's upcoming ALO-02 AdComm as their PDUFA date, but it gets the important part correct.
http://www.investing.com/analysis/here-are-two-large-cap-pharmas-with-pdufa-catalysts-next-month-200132618
Elite Pharmaceuticals ELTP
Shows Mean Drug Liking on Visual Analog Scale (VAS). Time is on horizontal axis. On the verticle axis, anything above 50 means they liked it, below 50 they disliked it. Notice the expected liking of snorted oxyIR (green). ELI-200 (blue) has ZERO drug liking, indicating an EFFECTIVE ADF. ELI-200 is *disliked* at the outset (blue line falls below the placebos (red & yellow)). This means it is an AVERSIVE ADF. Also, ELI-200 never bumps above the placebo line, indicating it is a DURABLE ADF.
ELTP 2 bead pharma ADF is EFFECTIVE, AVERSIVE, DURABLE, and MODULAR across the entire spectrum of opioid agonists and time-release profiles. Fully-licensable. The Golden Ticket.
Purdue's current technology works pretty well.
I am happy to criticize the notorious dose-dumping, easily-abused OxyContin. I've even implied that when better alternatives are available, OxyContin is at risk for FDA action due to its sketchy ADF. While that may be true, Purdue will never let that happen. I am certain they have OxyContin3 ready to go, probably using the Resistec technology they used for Hysingla (24 hour hydrocodone). Hysingla did receive the ADF label, and the pharmacokinetic and drug liking curves are reasonable. It's the exact same concept, a hardshell ADF that gums up when hydrated. But this formulation actually seems to work as an ADF. I'm sure that Purdue is trying to figure out a way to bring OxyContin3 to market such that they somehow weasel another 5 years of market exclusivity without generic competition, just like they did for OxyContin2. But even so, hopefully in the very near future they will have serious competition from multiple brand-name ADF's, including Xtampza, Rexista, ELI-201, and ALO-2.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000CrossR.pdf
This article is very good, rollin2nyte.
http://marketexclusive.com/weekly-biotech-report-covering-novo-nordisk-nysenvo-sanofi-sa-nysesny-kempharm-inc-nasdaqkmph/6455/
Fentanyl: Good, Bad, and Ugly
Fentanyl is mostly used in hospitals for IV drips and injections. Critical care docs tend to use a lot of fentanyl for sedation of intubated patients. There are no approved fentanyl tablets sold in the United States- nothing to add a naltrexone bead to. The only consumer product is Duragesic, the fentanyl patch. Duragesic is a great drug, the second most commonly prescribed opioid by me after oxyIR. The oldest of the olds seem to very nicely tolerate a 12 mcg patch, even if they never did well with oral drugs due to nausea, confusion, or somnolence. Some folks just plain out-live their spine and develop terrible degeneration and spinal stenosis, and I’ve gotten several up & moving again with a fentanyl patch when nothing else worked.
The patches can be abused by various measures, and there also have been deaths of children who accidently get hold of the patches. But the major problem with fentanyl is not abuse and diversion of patches or dead kids. The problem with fentanyl is that it is SYNTHETIC, and that is an extremely important difference. It may seem weird to think of OxyContin and SequestOx as agricultural products, but that is exactly what they are. All of the opioid drugs are manufactured from pharmaceutical API which is derived from industrial-farmed poppy. It requires massive infrastructure, including land and water and energy and workers and security and governance etc etc etc. But synthetic fentanyl is manufactured in a lab. All one needs is a decent chemist and access to the right compounds. With access to even rudimentary equipment, a devastating quantity of illicit fentanyl can be easily produced.
Heroin is also an agricultural product that requires massive infrastructure. It is no wonder that synthetic fentanyl has become cheaper and more readily available. But addicts actually try to avoid fentanyl because it significantly increases their tolerance to heroin and oxycodone. So dealers are cutting the more expensive, more desirable heroin with the cheaper, manufactured fentanyl, but they hide this from their customers. Unsuspecting addicts with high tolerance to heroin may not have cross-tolerance with fentanyl, and they have no idea how much they are injecting. Buyer beware. Fentanyl is especially killing people who do not even realize they are using it.
Illicit synthetic fentanyl is a big problem, but not one in which the ELTP antagonist ADF can be helpful.
There is no public data for Rexista.
Rexista is a hardshell ADF that gums up when hydrated to resist injection. IPCI says it is "difficult" to vaporize or inhale from burning. The technology could be applied to other agonists, but each will require reformulation.
IPCI has not to my knowledge ever disclosed any kind data, including HAL results. There are no pharmokinetic or drug liking curves available to compare, so nobody has any factual basis to say Rexista is any better or worse than any other hardshell ADF that gums up. One thing that confuses a lot of people is the overdose protection system known as PODRAS. It is purely conceptual, but the way IPCI has presented it tends to make some investors believe it is ready to file NDA now. PODRAS is years away from anything. Rexista with nPODDDs is the hardshell version supposedly ready to file NDA without Phase 3, so we'll get a look at the data soon enough.
One thing for sure Rexista does that Elite's platform does not:
http://files.shareholder.com/downloads/ABEA-43EQSZ/180376177x0x881307/0AA81A60-E645-4481-8DED-AD17516D579E/Roth_Investor_Conference_March_2016_upload_version.pdf
Another ADF implicated in serious heart damage.
The Canadians are learning about our pathetic game of Whack-A-Mole. Kill one drug, something else replaces it. Hydromorph Contin is time-release hydromorphone, which is better known as Dilaudid in this country, but I'm not aware of time-release Dilaudid available in USA. Very similar to the Opana ADF, the Hydromorph Contin ADF is easily injectable, but the extraction process introduces contaminates that cause big problems. A good reminder that just because a company says a drug is an ADF does not make it true.
http://www.ctvnews.ca/health/new-type-of-oxycodone-abuse-causing-spike-in-heart-infections-1.2912237
There is no more versatile ADF platform.
Some very interesting goings on recently around Opana “ADF” and generic oxymorphone formulations based on “original” Opana.
A lot of important background, some of which I’ve addressed in previous posts. The ADF version of Opana introduced by Endo in 2012 has been a complete disaster. Not only is the ADF version easily abused via intravenous injection, it is directly implicated in outbreaks of HIV and Hep C. The nature of the agonist requires frequent injections in order to avoid withdrawal, and the nature of the ADF requires large bore needles and extraction through steel wool, both of which are repeatedly shared and reused in a contaminated state.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113693008
Additional background: when ADF OxyContin was introduced in 2010, Original OxyContin was subsequently deemed unsafe due to abuse potential and the NDA approval revoked by FDA. This was uncontested by Purdue because it gave them an additional 5 years of market exclusivity with the new ADF version. Still reeling from this stink, FDA refused any such favor for Opana, saying the ADF version was not an improvement over the original version and therefore the original Opana NDA was kept in tact.
http://www.fiercepharma.com/legal/endo-scores-victory-opana-er-generics-patent-battle
Dear Purdue Pharma,
In the matter of your petition, we refer you to our previous reply in the matter of Arkell v. Pressdram.
Sincerely,
The FDA
Could happen any day, Lasers.
Remoxy will have its day in court.
See my previous post for drug liking curve.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122581242
http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=168113
This is not true.
Update on drugs to prevent oral abuse and overdose.
Some day, when there are are a plethora of ADF opioids that prevent oral abuse and overdose, any company still using the 2 bead system (or any ADF that does not prevent oral abuse) will be at risk. For now, there is not even one drug that can prevent oral abuse and overdose, but I watch these efforts closely. I said all sorts of mean things about KemPharm KP201 last week, and I want to redeem myself now because KP201 is a pretty cool molecule that does something no other drug can do: “Reduced hydrocodone exposure at oral doses >= 8 tablets” and “Reduced incidence of hypoxia at oral doses >= 8 tablets.”
KP201 is a prodrug ADF. It requires the GI tract to convert inactive prodrug into active opioid agonist. In theory, this would not only prevent nasal and intravenous usage but also would offer some protection from oral overdose. That is a blockbuster idea, if it works. Unfortunately for KemPharm investors, it was only moderately successful at two of the three. It gums up and is not suitable for injection. The nasal pharmacokinetic graphs were posted by me last week (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122440578). It only modestly delays Tmax, decreases Cmax, and decreases AUC. Nasal Drug Liking data is scarce in the public domain, suggesting poor results, confirmed by AdComm 18-2 vote against ADF label. Even with questionable snorting studies, it might have been different for KemPharm if the oral overdose protection worked better. But it doesn’t kick in until 8 tabs have been swallowed! 7.5mg hydrocodone x 8 = 60mg IR hydrocodone. Quite a serious nap, add alcohol and benzos for the final cut. Any bigger size tabs there would be virtually no protection: 15mg tabs x 8 = 120mg hydrocodone IR would cause life-threatening respiratory depression in any opioid-naive patient. By far, Kempharm was furthest along in this in this effort to prevent oral overdose, and they just went back to the drawing board.
The other two publicly-known candidates to prevent oral abuse and overdose are Acura’s LIMITX and Intellipharmaceutics’ PODRAS technologies. They both have their own patents and both use a gastic-acid based system to prevent usage of multiple pills. Both have received Fast Track designation from FDA, and Acura LimitX was also awarded a $300,000 federal grant for phase 1 development back in 2014. Acura’s system requires them to develop separate “microparticles” for each opioid agonist, while IPCI says PODRAS will work for any abusable drug, not just opioids.
I really like Bob Jones at Acura. He reminds me of Jerry Treppel- gives a frank and forthright discussion, and sometimes more. He updated us on LimitX progress during their conference call this month:
Dear WeeZuhl,
Some of our regular readers send questions to WeeZuhl. By request, this is a repost of a recent response, with a follow-up discussion on drugs that prevent oral abuse and overdose.
Agreed!!! LOL.
Amen to that! Say it again!
I like this part:
Great question, doc
Elite Pharmaceuticals Goals, Investor Presentation April 2016
http://ir.elitepharma.com/events_presentations
Lasers try this link:
http://ir.elitepharma.com/events_presentations