Update on Quillivant XR Shortage: New Supply Coming to Market
Production issues have limited supply of the popular liquid stimulant over the last year. Now, the drug’s new manufacturer says it is releasing additional supply to address regional shortages and has introduced a pharmacy locator service to help patients find their preferred medication in the short term.
Julie Rittenberry Goforth, a mother from Texas, recently tried to pick up her son’s ADHD medication from the pharmacy — only to be told that it was not available, and (incorrectly) that it may not be available ever again.
“[The] pharmacist told me they are discontinuing [the drug],” Rittenberry Goforth told ADDitude in a Facebook post. “It’s the only stimulant (brand) that has worked for my child.”
In fact, Quillivant XR is one of a number of brands of methylphenidate — a stimulant medication found to be the most effective, first-line treatment for ADHD in children, according to a 2018 study. Other methylphenidate options include Ritalin, Concerta, and Daytrana, among others. What sets Quillivant XR apart, and makes it so popular for parents of young children in particular, is its delivery system: It is the only liquid methylphenidate other than Methylin oral solution, and the only extended-release liquid methylphenidate on the market. For patients who experience trouble swallowing, don’t tolerate amphetamine-based stimulants, or need full-day coverage, the liquid Quillivant XR and chewable Quillichew ER are optimal methylphenidate medications.
Quillivant XR was approved by the Food and Drug Administration (FDA) in 2013. In filings with the Securities and Exchange Commission (SEC), the manufacturer of an orally disintegrating methylphenidate competitor called Cotempla XR-ODT suggested that physicians prescribed Quillivant XR an estimated 636,000 times in 2016. The first reported supply disruptions for both Quillivant XR and Quillichew ER, both manufactured by Pfizer at the time, came late last year. Patients reported trouble filling their prescriptions, and Pfizer sent a Drug Shortage Communication to healthcare professionals on November 8, 2017. The Quillichew shortage was resolved in February 2018, however supply problems lingered for Quillivant XR throughout 2018.
In September 2018, New Jersey-based Tris Pharma acquired the Pfizer subsidiary that held the patent for Quillivant XR and Quillichew ER. Tris specializes in manufacturing medications with unusual delivery systems — liquids, chews, and an extended release oral suspension amphetamine called Dyanavel XR. Since the transition from Pfizer to Tris began this Fall, ADDitude readers have reported supply challenges for Quillivant XR, certain dosages of which are reportedly unavailable or in short supply in several regions of the United States today.
“We are aware of local shortages of some strengths of Quillivant XR,” wrote Thomas Curatolo, Chief Commercial Officer at Tris Pharma, in an email to ADDitude on December 3. “We believe that Quillivant XR 300mg/60mL total volume bottles are widely available, while the availability of some other strength bottles is currently inconsistent. As you may be aware, Tris recently acquired the ownership rights to Quillivant XR and has been working directly and diligently with wholesalers and distributors to ensure seamless availability of the brand to patients. We are releasing additional supply into the market as quickly as possible and intend to ensure patients’ consistent access to all strengths of Quillivant XR as expeditiously as we can.”
In an effort to assist patients, Tris Pharma has developed a pharmacy locator service that is available by calling 866-395-1031.
Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine in Las Vegas, says she treats a number of children with ADHD, and often prescribes Quillivant XR. Inconsistent drug availability has impacted her patients’ treatment plans, she said.
“During the last shortage, I switched most of my patients to other methylphenidate products,” she said. “That’s not ideal, but I didn’t want to interrupt treatment. For patients, treatment interruption can have a significant impact on their school performance and home functioning.”
Similarly, Joseph Biederman, M.D., Chief of Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD at Mass General Hospital for Children in Boston reported that he’s aware of the shortages and has recommended alternative treatments to his patients and/or their patients.
It’s important to note that methylphenidate products are not like anti-psychotics and other medications used to treat depression and other conditions, in that administration disruptions don’t threaten significant health complications for patients. However, that doesn’t mean that medication distribution disruptions don’t carry consequences.
“In the best-case scenario, it’s a minor inconvenience,” said Keith McBurnett, Ph.D., a psychiatrist at the University of California San Francisco. “Worst case, a shortage results in these children coming off their medication for some time, and that can lead to problems at school. Many parents will take it in stride, because their children don’t take the medication consistently anyway, but it’s not ideal.”
Compounding the problem have been inconsistent and contradictory messages from pharmacists, prescribers, and the drug manufacturer. Amber Corn, a mother in Indiana, said she was told by her pharmacy that it could not order the drug because it was “discontinued.” However, the FDA’s database on drug shortages and discontinuations lists both Quillivant XR and Quillichew ER as “currently in shortage” and Tris Pharma says it is producing and releasing additional supply now.
Drs. Childress and McBurnett strongly recommend that parents of children affected by the Quillivant XR shortage consult with their physicians before changing medications or discontinuing treatment altogether. Methylphenidate alternatives such as Quillichew ER, the Daytrana patch, short-acting liquid Methylin, the extended-release orally disintegrating tablet Contempla XR, and short-acting liquid ProCentra meet the needs of many patients with ADHD. Still, switching medications is rarely straightforward.
“The chewables are available, but our insurance doesn’t cover the chewables, only the liquid,” said ADDitude reader Taylor Kirby. “The insurance company recommended changing to a generic or preferred medication, but we don’t want to change because Quillivant has been working so well on a low dose with limited side effects.”