CPhT CONNECT™ Magazine - Jan/Feb 2021

product news

NONPRESCR I PT I ON LOT I ON FOR HEAD L I CE The Food and Drug Administration (FDA) has approved a lotion to treat head lice for nonprescription use through a prescription- to-OTC switch. The FDA originally approved ivermectin (Sklice—Arbor Pharmaceuticals) lotion, 0.5% for the treatment of head lice infestation in individuals aged 6 months and older as a prescription drug in 2012. According to the Centers for Disease Control (CDC), an estimated 6-12 million cases of head lice infestation occur each year among U.S. children aged 3-11 years. Children more commonly experience head lice as groups of children often play closely together in areas such daycare centers, elementary schools, and their own homes. It is usually spread through direct head-to-head contact with an infected person, as the lice can only move by crawling rather than by flying or jumping. Head lice infestations can get out of hand quickly and by the time it is discovered a scalp could be completely covered. Lice can also be found on eyebrows and eyelashes. Head lice do not transmit a symptomatic disease and most individuals experience common symptoms of a sensation of something moving in the hair or a tickling feeling. Close inspection of the hair and scalp will find the nits or actual lice. If Once the lice have taken hold and reproduced the scalp becomes extremely itchy which is another tell-tale sign for parents. Excessive scratching from these symptoms may also lead to a secondary bacterial infection. Rx-to-OTC switches are generally initiated by the manufacturer of the prescription drug. For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective when used as directed in the proposed labeling. For an RX-to- OTC switch, the manufacturer must show that the average consumer could easily understand how to use the drug safely and effectively without the supervision of a healthcare professional. Once an infestation is established, a combination of nonpharmacologic and pharmacologic interventions are typically required, as none of the pediculicides are 100% ovicidal. The National Pediculosis Association recommends physical removal of the nits using an FDA-approved nit comb. You may have seen some of these as a child yourself. For example those little metal combs with the teeth very close together. When treating head lice, recommendations suggest

not to use more that the directed amount of lice medication unless instructed by a provider. Avoid medication contact with the eyes and do not treat the affected person more than two to three times with the same medication if it does not seem to be working. Additionally, some providers recommend it best not to use multiple treatment options at the same time. Sklice® is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use. The product will be marketed in the United States as a nonprescription drug and will no longer be available as a prescription drug. Consumers should read and follow the Drug Facts label for the nonprescription product and are urged to talk to their healthcare professional for any questions. Home remedies for lice treatment may include wet combing, to remove active lice and nits. Essential oils, such as plant and tea tree oils, are often used to suffocate lice, while agents such as olive oil and petroleum jelly are thought to smother lice if left in the hair overnight. The effectiveness of these treatments is not well established. OTC Sklice® lice medication can help reduce the need to be seen by a provider first allowing patients to treat infestations earlier thereby increasing success. Sklice®, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use. Source: https://www.pharmacist.com/article/ fda-approves-lotion-nonprescription-use-treat-head-lice https://www.fda.gov/news-events/press-announcements/fda-approves-lotion… https://www.fda.gov/news-events/press-announcements/ fda-approves-lotion-nonprescription-use-treat-head-lice https://www.pharmacytimes.com/news/help-patients-get-rid-of-head-lice

outweigh the known and potential risks for the drug. There are no adequate, approved and avail- able alternative treatments to bamlanivimab for the authorized population. As part of the eval- uation of the EUA, the agency imposed several quality measures to protect patients. The com- pany is required to implement these quality mea- sures to manufacture this drug under the EUA.

Bamlanivimab is a recombinant, neutraliz- ing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS- CoV-2. It is designed to block viral attachment and entry into human cells, thus neutraliz- ing the virus, potentially treating COVID-19. Bamlanivimab is authorized for patients ages 12 years and older who test positive for SARS- CoV-2 virus, weigh at least 40 kg (about 88 lb), and are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who adults ages 65 years or older or those who have certain chronic medical conditions. The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers. Bamlanivimab is admin- istered as a single dose of 700 mg via IV infusion over 60 minutes. According to the EUA fact sheets potential adverse effects, and drug interactions, must be made available to health care providers and to patients and caregivers which include anaphy- laxis and infusion-related reactions, nausea, diar- rhea, dizziness, headache, itching, and vomiting. Bamlanivimab is not authorized for COVID-19 patients who are hospitalized or require oxygen ther- apy because a benefit of bamlanivimab treatment has not been shown in these patients. Monoclonal antibodies such as bamlanivimab may be associ- ated with worse clinical outcomes when adminis- tered to hospitalized patients with COVID-19 who require high-flow oxygen or mechanical ventilation. Clinical trials of bamlanivimabwere shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease pro- gression within 28 days after treatment when com- pared to placebo. The safety and effectiveness of this investigational therapy continues to be evaluated. Source: https://www.pharmacist.com/article/ fda-issues-eua-bamlanivimab-treat-covid-19 https://www.fda.gov/news-events/press-announcements/coronavi- rus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19


COVID treatments are being approved at rapid rates during this [pandemic as companies try to stem and treat the wave of global infections. There are more and more drugs approved each week it seems. One such drug is an FDA- EUA (emergency use authorization) to Eli Lilly for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-mod- erate COVID-19 in adult and pediatric patients. The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and weighs any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the total- ity of the scientific evidence available, the agency determined that it is reasonable to believe that bam- lanivimab may be effective in treating non-hospi - talized patients with mild or moderate COVID-19. And, when used to treat COVID-19 for the autho- rized population, the known and potential benefits

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