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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 6 | Issue 12
June 15, 2024

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Onyda™ XR for Treatment of ADHD in Pediatric Patients

On May 29, 2024, the U.S. Food and Drug Administration (FDA) approved Onyda™ XR (clonidine hydrochloride) as the first and only liquid non-stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older. ADHD is a mental health condition that develops in early childhood and can continue into adulthood. Individuals affected by ADHD experience symptoms such as difficulty paying attention, restlessness and impulsive behavior. Onyda™ XR is a non-stimulant with nighttime dosing that works to improve impulsivity and hyperactivity in ADHD. Non-stimulant ADHD therapies are important treatment options for patients who have not benefitted from stimulant medications, or those who may not be good candidates for them due to risk of side effects or abuse potential. Additionally, the extended-release liquid formulation allows for more convenience with dosing and may help those who have difficulty swallowing tablets, especially younger patients. FDA approval for Onyda™ XR was provided based on data from three clinical trials which measured the medication’s effect on symptom control. In the trials, clonidine hydrochloride extended-release tablets were used alone or as an add-on treatment with another ADHD medication (like a stimulant) compared to placebo. The results of these studies showed that extended-release clonidine was superior to placebo, significantly improving ADHD symptoms regardless of using it alone or in addition to a stimulant. The most common side effects of Onyda™ XR include fatigue, irritability, insomnia and constipation. Onyda™ XR should not be taken with other medications containing clonidine. This medication is expected to be available in pharmacies in the second half of 2024.

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Drug Safety

Voluntary Recall for Buprenorphine Hydrochloride Injection Carpuject™ and Labetalol Hydrochloride Injection Carpuject™ Cartridges

On May 21, 2024, Hospira, Inc. announced that it was voluntarily recalling 2 lots of Buprenorphine Hydrochloride Injection Carpuject™ cartridges and 3 lots of Labetalol Hydrochloride Injection Carpuject™ cartridges. The recall was initiated due to the potential for incomplete crimp seals on the units. An insufficient seal on the cartridges could allow the medication to leak out, leading to a lower dose administered and reduced therapeutic effect. It could also allow microbial contamination of the product, increasing the risk of a systemic infection that may require additional medical treatment. Buprenorphine HCl Injection is indicated for the management of severe pain requiring an opioid analgesic and for which alternate treatments are inadequate. Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension. The affected Buprenorphine HCl Injection lots are HJ3965 and HJ8546 with expiration dates of September 2024 and October 2024, respectively. The affected Labetalol HCl Injection lots are HJ7566, HN8747, and HN8749 with expiration dates of May 2025, September 2025 and September 2025, respectively. Wholesalers and hospitals have been advised to discontinue use, stop distribution and arrange for the return of any recalled products in their inventory. There have been no adverse events related to this recall to date, but patients should contact their health care provider if any problems arise from use of this product. Adverse effect should be reported to the  FDA’s MedWatch Adverse Event Reporting program. 

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From the Pharmaceutical Industry

FDA Approves the First mRNA Vaccine Against RSV

On May 31, 2024, Moderna, Inc. announced the FDA approval of mResvia® (mRNA-1345) for protection against lower respiratory tract infection caused by respiratory syncytial virus (RSV) in adults 60 years and older. RSV is a highly contagious respiratory virus that typically causes mild, cold-like symptoms. However, it can cause pneumonia and lead to hospitalization in vulnerable populations such as infants and older adults. It is estimated that 6,000-10,000 older adults die each year in the U.S. due to RSV infection.

mResvia® is the third vaccine to be approved for the prevention of RSV. It is the second type of vaccine to employ messenger RNA (mRNA) technology, following the use of mRNA in vaccines against the COVID-19 virus. The two previously approved RSV vaccines, Abrysvo® and Arexvy, use recombinant DNA technology. The safety and efficacy of mResvia® was established in a large clinical trial of adults 60 years and older. The participants received a single injection of either mResvia® or placebo. mResvia® was found to be 83.7% effective in preventing lower respiratory virus infection caused by RSV. Common adverse reactions included injection site pain, fatigue, headache, muscle pain and joint pain. FDA granted mResvia® a breakthrough therapy designation. This new vaccine is expected to be available prior to the 2024-2025 RSV season. 

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FDA Approvals

New FDA Approvals

New Drug: Bkemv™ (eculizumab-aeeb)

Bkemv™ injection, a biosimilar to Soliris®, is indicated for adult patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce the breakdown of red blood cells, and for patients 2 months and older with atypical hemolytic uremic syndrome (aHUS). Both PNH and aHUS are rare blood disorders that cause destruction of red blood cells, blood clots and kidney disease. [5/28/2024 - Amgen Inc.]


New Drug: Imdelltra™ (tarlatamab-dlle)   

Imdelltra™ injection is indicated for adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. [5/16/2024 - Amgen Inc.]

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New Generics

New Generics Entering the Marketplace

Emflaza® (deflazacort)

Indication: Treatment of Duchenne muscular dystrophy (DMD) in patients 2 years and older. 

Dosage Form/Strength: 22.75mg/ml oral suspension

Average Wholesale Price (AWP): Generic = $7,583 | Brand = $8,089