By Sree Roy
Ensuring a drug is absorbed as intended is certainly more important than the medicine’s palatability, but wouldn’t it be great to have both efficacy and a decent taste?
For one narcolepsy drug, that conundrum was explored via a poster presentation at SLEEP 2024. LUMRYZ, approved by the US Food and Drug Administration in 2023, is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.
“None of the oxybates, in general, have a particularly appealing taste,” says Maggie Lavender, MSN, APRN, FNP-C, a nurse practitioner with Comprehensive Sleep Medicine Associates and a co-author who helped interpret the results of the study Stability of Once-Nightly Sodium Oxybate in Alternative Liquid Reconstitution Vehicles. Like other oxybates for narcolepsy, LUMRYZ is delivered in powdered form, which patients mix with water before drinking immediately before bed.
Sodium oxybates taste salty. “Taste is typically not a deterrent to our patients,” Lavender says. “But in those sensitive cases, we may be able to help them.”
For the study, investigators poured a packet of LUMRYZ into Milli-Q water (the control), Crystal Light Raspberry Lemonade, MiO Fruit Punch Concentrate, and alkaline water to glean the impacts that dilutants other than water have on the dissolution of the medication. These beverages were selected because of their commonplace availability and palatability, Lavender says.
LUMRYZ is ideally taken immediately after a vigorous 60-second shake in water. “You’re supposed to take it within 30 minutes to have the best outcome of the medication,” Lavender says. During the study, after 15 minutes LUMRYZ 4.5 g was 50% dissolved in the control, 51% in the Crystal Light and MiO, and 49% in alkaline water. The 9 g dose was 50% dissolved in control and Crystal Light and 51% in MiO and alkaline water. “The minor variations in dissolution rates were very insignificant,” Lavender says.
The investigators also tested the alternate dilutants’ impact on LUMRYZ’s pH. Consisting of immediate elements and pH-dependent controlled-release granules, LUMRYZ is designed to decrease the pH so the controlled-release granules will stay intact until the drug reaches the alkaline environment in the gut.
Before the addition of LUMRYZ, the pH of the control, Crystal Light, MiO, and alkaline water was 7.03, 3.02, 2.95, and 9.53, respectively. For LUMRYZ 4.5 g in the control, Crystal Light, MiO, and alkaline water, the pH was 5.6, 5.3, 5.4, and 5.6 at five minutes. For the 9 g dose in the control, Crystal Light, MiO, and alkaline water, the pH was 5.7, 5.5, 5.6, and 5.7 at five minutes—minor variations that Lavender also characters as “very insignificant.”
The upshot, according to Lavender, is: “The clinical implications of this in vitro study are that these alternate dilutants can be used.” So patients can get an effective dose of their medication and be OK with its taste too.
Whether mixing LUMRYZ with water or one of these alternate dilutants, Lavendar always tells patients to shake it for the full minute. “The technology that allows the single dose at bedtime is comprised of granules for both immediate and controlled release. They do not dissolve fully, so you have to shake this medicine for a full 60 seconds. I make sure to tell my patients and to reiterate that every time to set that expectation so they don’t notice any grittiness.”
LUMRYZ has a boxed warning as a central nervous system depressant and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy. Most common adverse reactions reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting.
ID 32360015 © Hyrman| Dreamstime.com
Leave a Reply