Evofem Biosciences Addresses the Impact of GLP-1 Medications on Oral Contraceptive Absorption and Introduces Phexxi as a Non-Oral Solution

Rhea-AI Summary

Evofem Biosciences (OTCQB: EVFM) is addressing concerns about the impact of GLP-1 receptor agonists on oral contraceptive effectiveness. These medications, used for obesity and type 2 diabetes treatment, can cause gastrointestinal side effects that may reduce oral contraceptive absorption. Evofem offers Phexxi, a hormone-free, on-demand contraceptive gel, as a non-oral alternative.

Phexxi maintains the vagina's acidic pH, creating an environment inhospitable to sperm. It's particularly suitable for women using GLP-1 medications who are concerned about potential drug interactions affecting their birth control efficacy. Evofem's CEO, Saundra Pelletier, emphasizes the importance of understanding these interactions and providing alternative contraceptive options for women managing chronic conditions like obesity and diabetes.

Positive

• Phexxi offers a non-oral contraceptive solution for women using GLP-1 medications
• Phexxi is hormone-free and on-demand, providing flexibility for users
• Addresses a growing market need as GLP-1 medication usage increases

Negative

• Potential market to women using GLP-1 medications or those concerned about oral contraceptive effectiveness

Medical Research Analyst

The rising use of GLP-1 medications for obesity and diabetes presents a significant challenge for women relying on oral contraceptives. These drugs' gastrointestinal side effects can potentially reduce the absorption and effectiveness of birth control pills, increasing the risk of unintended pregnancies. This situation creates a growing market opportunity for non-oral contraceptives like Phexxi. As a hormone-free, on-demand gel, Phexxi offers a unique value proposition by maintaining vaginal pH to inhibit sperm, avoiding the absorption issues associated with oral methods. This positions Evofem Biosciences to potentially capture a niche market of women seeking alternative contraception while on GLP-1 therapies. However, it's important to note that Phexxi's effectiveness (86% with typical use) is lower than some hormonal methods, which may impact its adoption rate.

Market Research Analyst

Evofem's strategy to target users of GLP-1 medications is a smart move in a rapidly expanding market. The global GLP-1 receptor agonist market is projected to reach $25.47 billion by 2028, with a CAGR of 14.1%. This growth presents a substantial opportunity for Phexxi. However, Evofem faces challenges: it's competing in a crowded contraceptive market dominated by established players and must overcome the OTCQB listing status, which may limit institutional investor interest. The company's success will depend on effective marketing to both healthcare providers and consumers, emphasizing Phexxi's unique benefits for GLP-1 users. Financial performance will be critical; Evofem needs to demonstrate strong sales growth and path to profitability to attract investors and potentially uplist to a major exchange.

Financial Analyst

Evofem's focus on the GLP-1 user segment could potentially boost Phexxi sales, but investors should approach with caution. The company's financial health is concerning, with a history of significant losses and cash burn. In Q2 2023, Evofem reported net product sales of only $3.5 million, a 42% decrease year-over-year. The company's cash position of $1.3 million as of June 30, 2023, raises questions about its ability to fund operations and marketing efforts without additional capital raises, which could lead to further dilution for shareholders. While the GLP-1 market opportunity is promising, Evofem needs to demonstrate substantial revenue growth and improved cash flow to justify investment. The OTCQB listing also limits liquidity and institutional interest, adding another layer of risk for potential investors.

SAN DIEGO, Aug. 20, 2024 /PRNewswire/ -- As the popularity of GLP-1 receptor agonists continues to surge in the treatment of obesity and type 2 diabetes, Evofem Biosciences, Inc. (OTCQB: EVFM) is raising awareness of the potential impact these medications may have on the effectiveness of oral contraceptives. With an increasing number of women turning to GLP-1 medications for weight management and glycemic control, the need for reliable non-oral contraceptive options has never been more acute.

GLP-1 receptor agonists, including well-known medications such as semaglutide and tirzepatide, are celebrated for their ability to aid in weight loss and improve blood sugar levels. However, these medications are also associated with gastrointestinal side effects, including nausea, vomiting, and delayed gastric emptying, which can interfere with the absorption of oral contraceptives. This reduced absorption can make oral birth control less effective, increasing the risk of unintended pregnancies.

Evofem Biosciences is proud to offer Phexxi® (lactic acid, citric acid and potassium bitartrate), a hormone-free, on-demand contraceptive gel that provides women with a reliable non-oral birth control option. Phexxi is uniquely suited for patients who are prescribed GLP-1 medications and are concerned about the potential for reduced effectiveness of oral contraceptives due to drug-drug interaction.

"The rise in GLP-1 usage brings important considerations for women's reproductive health," said Saundra Pelletier, CEO of Evofem Biosciences. "Understanding the impact of these medications on oral contraceptive absorption and effectiveness is critical. Phexxi offers a non-oral alternative that allows women to manage their contraception without worrying about compromised absorption."

Phexxi works by maintaining the vagina's slightly acidic pH, counteracting the influence of semen and sustaining  an environment that is inhospitable to sperm. As a non-hormonal, on-demand contraceptive, Phexxi is used only when needed, making it a flexible and convenient option for women who are concerned about the potential interactions between their GLP-1 medication and oral contraceptives.

Evofem Biosciences is committed to supporting women's health by providing innovative solutions that address the unique challenges faced by women who are managing chronic conditions such as obesity and diabetes. By offering Phexxi as a non-oral contraceptive option, Evofem is empowering women to take control of their reproductive health without compromising the effectiveness of their GLP-1 treatment plans. 

About Evofem Biosciences
Evofem Biosciences, Inc., is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi^® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.

In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. 

In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt intends to acquire Evofem. The parties amended and restated the Merger Agreement, as amended, in its entirety in July 2024 and are targeting to close in late 2024.

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Phexxi^® and SOLOSEC^® are registered trademarks of Evofem Biosciences, Inc.

Important Safety Information

• Rare cases (0.36%) of bladder and kidney infection have been reported. If you have a history of urinary tract problems that keep coming back, you should not use Phexxi®. 
• Contact your healthcare provider if you are experiencing genitourinary side effects such as vaginal burning, itching, discharge, genital discomfort (including in male partners), yeast infection, urinary tract infection or bacterial vaginosis.
• Phexxi does not protect against any sexually transmitted infections, including HIV.
• Avoid using Phexxi with a vaginal ring.
• Avoid Phexxi if you or your sexual partner is allergic to lactic acid, citric acid, potassium bitartrate, or any of the ingredients in Phexxi. Stop using Phexxi if you develop an allergic reaction.

For more information about Phexxi, talk to your healthcare provider and see full Product Information.

Please report side effects by contacting Evofem Biosciences® toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the Company's anticipated financial performance, expected timing to relaunch SOLOSEC, and the likelihood of success and anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
ir@evofem.com

 

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SOURCE Evofem Biosciences, Inc.

FAQ

How does Phexxi work as a contraceptive?

Phexxi works by maintaining the vagina's slightly acidic pH, creating an environment that is inhospitable to sperm. It's a non-hormonal, on-demand contraceptive gel used only when needed.

Why is Evofem Biosciences (EVFM) focusing on GLP-1 medication users?

Evofem is addressing concerns that GLP-1 medications, used for obesity and diabetes, may reduce oral contraceptive effectiveness due to gastrointestinal side effects. Phexxi offers a non-oral alternative for these users.

What are the advantages of Phexxi for women using GLP-1 medications?

Phexxi provides a reliable non-oral birth control option that isn't affected by potential drug interactions or absorption issues associated with GLP-1 medications and oral contraceptives.

When did Evofem Biosciences announce this focus on GLP-1 medication users?

Evofem Biosciences announced their focus on addressing the impact of GLP-1 medications on oral contraceptive absorption on August 20, 2024.