By Dr. Jeffrey Fudin
Same church different pew you ponder? It’s not that simple.
Almost a year to the day since the availability of Zohydro ER (hydrocodone extended release, manufactured by Zogenix), there is now another kid on the block; Hysingla ER (hydrocodone extended release, manufactured by Purdue). Nobody can deny that Zogenix paved a pretty hefty path to bring and keep this on the market.
Along the way was a pretty disheartening road. But no matter how many unearthed faults were found in the path, they were minuscule compared to the faulted rhetoric among media sensationalists and politicians. With one road block after another, it became clear that politicians were more interested in saying something (anything) for the attention than they were about the truth. In fact, their futility and sensationalistic journalism promulgated numerous blogs here.
On the one hand I suppose that was cultivating for this site and our readers, but unfortunately it was on the backs (perhaps literally) of legitimate pain sufferers that might otherwise benefit from an extended release formulation of hydrocodone. Rehb.com provides some interesting infographics that break down nationally and by state, various permutations of how “Admissions to treatment facilities has been steady or rising for the past 20 years, yet it seems elected officials spend less and less of their time on the floor of the House and Senate talking about it.”
The indisputable facts are that since Zohydro ER release in March 2014, there have been over 50,000 prescriptions filled (almost 3 million capsules dispensed) yet an extremely low incidence of abuse, misuse, and diversion reported in the surveillance databases.
Do note however that because schedule II drugs are not allowed automatic refills, each Rx is considered an initial fill, so the 50,000 prescriptions does not equate to 50,000 patients. I imagine we will see similar safety and surveillance data for Hysingla ER in the months ahead.
So, you ask, what are the differences? On the surface it seems simple; 1 ) Hysingla ER is once daily dosing and Zohydro ER is twice daily dosing; 2 ) Hysingla ER has an FDA label as “abuse deterrent” and Zohydro ER does not (yet); and 3 ) Hysingla ER is a tablet and Zohydro ER is a capsule.
Let’s break this down, because ultimately it really should be about the patient.
History tells us that once daily or twice daily intended dosage forms sometimes require twice or three times daily dosing respectively. Third party payers have notoriously used this as an excuse not to pay. By way of example, OxyContin (oxycodone extended release) is indicated for every 12 hour dosing, but it is not uncommon to see it appropriately prescribed every 8 hours instead of every 12 hours. The same is true for Avinza (morphine extended release). Avinza is indicated for every 24 hour dosing, but it is not uncommon to see it prescribed every 12 hours instead of once daily. The best example where reality, practicality, and just plain good medicine flew in the face of the original package insert is brand name Duragesic, fentanyl transdermal (TD).
The original package insert required every 72 hour changes of the patch. Some patients didn’t receive adequate analgesia for that period of time – the manufacturer recommendation therefore was to raise the patch dosage to the next highest strength. Sure, this would therefore raise the overall serum levels thus extending the therapeutic blood levels perhaps into the third day, but was it clinically the best thing for the patients and did it adhere to basic therapeutic principals? The answer is no! We always want to give the lowest effective dose. If that could be achieved by remaining on the same fentanyl dose and changing it more frequently, then that is the proper approach. See Medscape, Can Fentanyl Patches Be Replaced Sooner to Improve Pain Control?
To address point #1 above, the once daily practicality and convenience of Hysingla ER is of course a wonderful thing. For a caregiver that can only get to the home once daily, it is a Godsend. But, although it is a nice option for many, some patients might be better off on a lower overall 24 hour dose by using the every 12 hour dosage form of Zohydro ER.
To address point #2, abuse deterrent technology (ADT) is a wonderful thing too (kudos to Purdue), but ADT is not the be all and end all of substance abuse; it is simply another option. To read more about that, see the Pharmacy Times article Abuse-Deterrent Opioid Formulations: Purpose, Practicality, and Paradigms. For the record, Zogenix ER has received FDA approval for their new abuse deterrent formulation.
And finally to address point #3, Hysingla ER is a tablet and Zohydro ER is a capsule. From experience, it is clear that some patients are better able to swallow one compared to the other. For some, the fear of swallowing a tablet (a form of phagophobia) is insurmountable. For those that cannot swallow a tablet, I do prefer a capsule and the patient is told to sit or stand straight, place the capsule in their mouth, sip a mouthful of water, and look down towards the table or floor. The capsule floats to the back of the throat – now swallow. Although this often works, some might do better with a small tablet.
Hysingla ER is available by tablet in milligram strengths of 20, 30, 40, 60, 80, 100, and 120.
Zohydro ER is available by capsule in milligram strengths of 10, 15, 20, 30, 40, and 50.
For the benefit of media sensationalists and political mouthpieces, let me save you the trouble and embarrassment this time around, because if tempted, I will call you out publically again. Hysingla ER 120mg is not 3 times more potent than Zohydro ER 40mg. They are equipotent because hydrocodone is hydrocodone is hydrocodone as explained in the previous post here, ZOHYDRO: What weighs more – A pound of feathers or a pound of hydrocodone?
Kudos to the two companies that fought to bring these new options to market for patients that can truly benefit from a single entity extended release dosage form of hydrocodone.