PDR Drug Update - June 2023

Important New Tools for Opioid Misuse Intervention

The statistics surrounding opioid abuse and its potentially life-threatening consequences are increasingly concerning. According to figures presented by the CDC, overdoses from opioids are responsible for more than 190 deaths each day. This critical public health issue was exacerbated by the COVID-19 pandemic, and there is no indication of its magnitude lessening. Strategies to aid the fight against the crisis include developing new options for treating opioid use disorder and expanding access to proven means for mitigating the harm of drug abuse.

A new approval granted at the end of May 2023 offers a supportive treatment for patients dealing with opioid use disorder. Known as Brixadi (buprenorphine), the therapy is available as both a weekly and a monthly extended-release injection for subcutaneous administration only. Patients who are not receiving buprenorphine treatment prior to using Brixadi must first receive a test dose of 4mg transmucosal buprenorphine to verify their tolerability to the drug. Only healthcare providers may administer the medication, which should be integrated into a holistic therapeutic approach involving counseling and other supportive treatment measures.

The FDA also approved in May a new prescription nalmefene nasal spray option, called Opvee (nalmefene). This product is intended to be used as emergency treatment for opioid overdose in individuals aged 12 years and above. The benefits of this drug include that it is a long-acting opioid antagonist with a duration of action similar to most opioids, including fentanyl. Nalmefene can reverse opioid effects such as respiratory or central nervous system depression.

Several weeks earlier, another unique advancement in opioid harm reduction options came with the approval of the first over-the-counter opioid reversal agent, Narcan (naloxone HCl). The drug’s ability to compete for the same receptor sites as opioids allows it to negate their effects, impeding sedation and respiratory depression. Multiple factors supported the determination to make Narcan available without a prescription through retail sources. In general, it has a low risk profile. If the drug is used in an individual who does not have opioids in their system, Narcan will not have an adverse effect. The product is not difficult to use, even in an emergency situation. It is easy to transport and, as a nasal spray, contains no risk of needle-stick injury. Related costs and access to the drug are yet to be determined, but availability is planned for the current year.

Stay informed about emergent drug information, including potentially life-saving opioid antagonists, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, mobilePDR, available for free from your favorite app stores.

FDA New Approvals

Brixadi

The FDA has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use, a new weekly and monthly medication for moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product. Learn more about Brixadi

Epkinly

The FDA has approved Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma, after two or more lines of systemic therapies. Learn more about Epkinly

Inpefa

The FDA has approved Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The broad label encompasses heart failure patients across the full range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes. Learn more about Inpefa

Miebo

The FDA has approved Miebo (perfluorohexyloctane) ophthalmic solution for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation. Learn more about Miebo

Opvee

The FDA has approved Opvee (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. Learn more about Opvee

Posluma

The FDA has approved Posluma (flotufolastat F 18) injection for positron emission tomography of prostate‐specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate‐specific antigen level. Learn more about Posluma

Paxlovid

The FDA has approved Paxlovid (nirmatrelvir; ritonavir) tablets for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Learn more about Paxlovid

Veozah

The FDA has approved Veozah (fezolinetant) 45mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Veozah is the first nonhormonal neurokinin 3 receptor antagonist approved to treat VMS due to menopause. Learn more about Veozah

Vyjuvek

The FDA has approved Vyjuvek (beremagene geperpavec-svdt) for the treatment of patients aged six months or older with dystrophic epidermolysis bullosa. Learn more about Vyjuvek

Xacduro

The FDA has approved Xacduro (durlobactam; sulbactam) for injection as a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex. Learn more about Xacduro

Yuflyma

The FDA has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Learn more about Yuflyma

Zynyz

The FDA has approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. Learn more about Zynyz

FDA New Indications

Ayvakit

The FDA has approved Ayvakit (avapritinib) for the treatment of adults with indolent systemic mastocytosis. This is the third indication for Ayvakit. Learn more about Ayvakit

Breo Ellipta

The FDA has approved an expanded indication for Breo Ellipta (fluticasone furoate/vilanterol) inhalation powder to include maintenance treatment of asthma in children aged 5 to 17 years. Previously, Breo Ellipta was only approved for maintenance treatment of asthma in adults. Learn more about Breo Ellipta

Caldolor

The FDA has approved labeling for Caldolor (ibuprofen) injection for intravenous use to now include use in infants. The non-narcotic agent may now be administered for the treatment of pain and fever in patients aged three months to six months. Learn more about Caldolor

Lexapro

The FDA has approved an expanded indication for Lexapro (escitalopram) for generalized anxiety disorder to include patients aged 7 to 17 years. Learn more about Lexapro

Rexulti

The FDA has approved Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer's disease. Learn more about Rexulti

Rinvoq

The FDA has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers. This is the seventh FDA approval for Rinvoq across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease. Learn more about Rinvoq

Ultravist

The FDA has approved a new indication for Ultravist (iopromide) injection for contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound. Learn more about Ultravist

FDA Alerts

G-Supress DX Pediatric Cough Drops

The FDA is alerting consumers and pharmacies to not use or sell a specific lot of over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR, because it contains the incorrect product and may cause patient harm. Learn more about the G-Supress DX Pediatric Cough Drops alert

Prescription Stimulants for ADHD and Other Conditions

The FDA is requiring updates to the Boxed Warning and other information for prescription stimulants to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse. Learn more about drug safety communication for prescription stimulants for ADHD and other conditions

Labeling Updates

Key
Boxed Warning
Other Warnings*

*Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications
Updates to Indications/Dosage
Other Updates†

†Other labeling changes; added to PDR database

No Lupron Depot-PED boxed warning				Lupron Depot-PED (leuprolide acetate)
No Qulipta boxed warning				Qulipta (atogepant)

Rinvoq (upadacitinib)

June 2023