Azotemia

-- Onshoring of NUZYRA is a Key Deliverable in Company’s Partnership with U.S. Biomedical Advanced Research and Development Authority (BARDA) to Enhance National SecurityBOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, announces that its U.S. supply and manufacturing capabilities for its novel antibiotic NUZYRA® (omadacycline) are now complete. NUZYRA is the company's broad-spectrum, novel antibiotic available in both intravenous and oral formulations approved by the U.S. Food and Drug Administration (FDA) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). “Establishing a U.S. manufacturing and supply chain is the culmination of one of the most important elements of our public-private partnership with BARDA, an agreement intended to strengthen our national security,” said Evan Loh, M.D., Paratek chief executive officer. “This onshoring milestone is significant because it ensures that NUZYRA has a secure domestic supply chain that reduces dependency on foreign production and decreases the national security risk for the manufacturing and supply of antibiotics.” Major onshoring milestones that established the U.S. capabilities included the successful technology transfer by Paratek and its manufacturing partners and related FDA approval/implementation for 1) U.S. manufacturing of NUZYRA tablets in 2022; 2) U.S. manufacturing of the active pharmaceutical ingredient (API) as of August 2024; and 3) U.S. manufacturing of NUZYRA’s IV formulation (vials) in October 2024. “Paratek continues to deliver on the milestones of this important agreement with BARDA, in many cases exceeding agreed-upon timelines, thanks to ongoing, highly productive collaboration and communication between BARDA and Paratek,” said Randy Brenner, Paratek's chief development and regulatory officer. “We are grateful to BARDA for their partnership and look forward to completing our studies to support our sNDA filing for NUZYRA for treatment and prophylaxis of pulmonary anthrax in the near term.” This project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00001. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval for both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021 and in Macao for the treatment of CABP and ABSSSI in May 2023. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. Paratek is conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. About NUZYRA®NUZYRA® (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. MEDIA CONTACT: Christine Fanelle Scient PR Christine@ScientPR.com215-595-5211

Generated 3Q 2024 net FUROSCIX® revenue of $10.0 million, up 164% from Q3 2023 Received approval of label expansion to include New York Heart Association (NYHA) Class IV Patients Announced positive pharmacokinetic/pharmacodynamic (PK/PD) data on Autoinjector program Completed $125 million transformative financing in a combination of debt and equity that is anticipated to fund the Company through expected profitability Company to host investor conference call and webcast today, Wednesday, November 13th, at 4:30pm ET BURLINGTON, Mass., Nov. 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, today announced financial results for the third quarter ended September 30, 2024, and provided a business update. Business Update For the third quarter ended September 30, 2024, scPharmaceuticals reports: Net FUROSCIX revenue of $10.0 million, representing a 24% increase from the second quarter of 2024Approximately 10,800 FUROSCIX doses filled, representing a 16% increase from the second quarter of 2024Approximately 6.8 doses per prescription, up from 6.3 in the second quarter of 2024Approximately 3,100 unique prescribers from launch until the end of the third quarter of 2024, up approximately 14% from the end of the second quarter of 2024Gross-to-net discount of 15.7% in the third quarter of 2024, compared to 8% in the second quarter of 2024Received direct purchases from 14 Integrated Delivery Networks (IDNs)/hospital systems year to datePrice increase of FUROSCIX by 5.5% at the end of September of 2024 expected to have a positive impact on product revenues Transformative Financing Through Profitability: In August 2024, scPharmaceuticals announced concurrent equity, debt and royalty financings totaling up to $175 million. The transactions were comprised of a $50 million equity financing with leading life science investors, as well as both a $75 million senior debt facility and $50 million in a synthetic royalty agreement with Perceptive Advisors. The combined $175 million is anticipated to fund scPharmaceuticals’ operations through expected profitability.NYHA Class IV Approval: In August 2024, scPharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted approval for FUROSCIX, expanding the indication to include New York Heart Association Class IV chronic heart failure patients.PK/PD Data for Autoinjector: In August 2024, scPharmaceuticals announced positive PK/PD data that met all primary and secondary endpoints. scPharmaceuticals is continuing to progress towards its targeted submission of a Supplemental New Drug Application (sNDA) to the FDA by the end of January 2025.sNDA FUROSCIX Filing in Chronic Kidney Disease (CKD): In July 2024, scPharmaceuticals announced that the FDA has accepted for filing the Company’s sNDA seeking to expand the FUROSCIX indication to include treatment of edema due to fluid overload in patients with CKD. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025. “The continued growth of FUROSCIX net revenue is encouraging, particularly as we have begun to see increased penetration into the Class IV chronic heart failure patient population following the FDA`s approval of the FUROSCIX expanded indication in August. We anticipate the expansion of the sales force that we completed in late September to have a potentially meaningful impact on sales moving forward. In addition, we saw a significant increase in the FUROSCIX purchase flow from IDNs and hospital systems,” stated John Tucker, President, and Chief Executive Officer of scPharmaceuticals. “We remain committed to our FUROSCIX lifecycle initiatives, including the development of our Autoinjector. The Autoinjector is anticipated to meaningfully reduce cost of goods sold over the medium-to-long-term. We continue to advance our pre-launch activities in anticipation of our PDUFA target action date on March 6, 2025, in patients with fluid overload due to CKD. In preparation for the potential indication expansion, we have conducted in depth market research, identified key opinion leaders, and have incorporated high impact nephrology offices that are already treating heart failure patients that also have CKD into our call plan.” Third Quarter 2024 Financial Results Product revenues were $10.0 million for the third quarter of 2024, compared to $3.8 million for the third quarter of 2023. Cost of product revenues were $3.3 million for the third quarter of 2024, compared to $1.1 million for the third quarter of 2023. The increase in both product revenues and cost of product revenues for the quarter ended September 30, 2024, was due to an increase in demand of FUROSCIX further into commercial launch, and related manufacturing costs. Research and development expenses were $3.5 million for the third quarter of 2024, compared to $3.4 million for the third quarter of 2023. The increase in research and development expenses for the quarter ended September 30, 2024, was primarily due to an increase in clinical study costs, offset by a decrease in pharmaceutical development, quality, regulatory, and employee related costs. Selling, general and administrative expenses were $21.3 million for the third quarter of 2024, compared to $14.1 million for the third quarter of 2023. The increase in selling, general and administrative expenses for the quarter ended September 30, 2024, was primarily due to costs associated with entering into the Credit Agreement and Guaranty and Revenue Purchase and Sale Agreement in August 2024, employee related costs, commercial costs, patient support, and professional service costs, offset by decreases in taxes and insurance. scPharmaceuticals reported a net loss of $35.1 million for the third quarter of 2024, compared to $15.6 million for the third quarter of 2023. The increase in net loss for the third quarter of 2024, was primarily due to one-time charges related to the extinguishment of debt and accounting for the new financial instruments scPharmaceuticals entered into in August 2024. scPharmaceuticals’ net loss for the third quarter of 2024 was $0.75 per share. The $0.75 per share was burdened by one-time charges of $0.47 per share. scPharmaceuticals ended the third quarter of 2024 with $91.5 million in cash and cash equivalents, compared to $76.0 million in cash, cash equivalents, and short-term investments as of December 31, 2023. As of September 30, 2024, scPharmaceuticals’ total shares outstanding was 50,040,134. Conference call and webcast information scPharmaceuticals’ management will host a conference call and webcast to review the Company’s third quarter 2024 results today, Wednesday, November 13th, at 4:30 p.m. EST. Participants should dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) with the conference code 13749995. To access the Call me™ feature, which avoids having to wait for an operator, click here. The live webcast and replay of the conference call can be accessed here or under “News & Events” in the Investor Relations section of the Company’s website, www.scpharmaceuticals.com. FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure. IMPORTANT SAFETY INFORMATION FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation or medical adhesives and in patients with hepatic cirrhosis. Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment. Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms. The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain. For more details, please read the full Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf. About scPharmaceuticals At scPharmaceuticals, we are powered by passion, driven by patient care. Our Mission is focused on advancing cardiorenal care through innovative, integrated treatments that address unmet patient needs. Our goal is to become the foremost advocate for patient-centric cardiorenal care, driving global health improvements through specialized, multidisciplinary approaches. scPharmaceuticals is expanding its reach, offering integrated therapies and products that address diverse healthcare needs and potentially improve the lives of our patients. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the development and commercialization of products, such as the Autoinjector, that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs and costs of goods sold; our commercial strategy for FUROSCIX and anticipated sales; the PDUFA target action date of March 6, 2025 related to the NDA seeking to expand the FUROSCIX indication to include the treatment of fluid overload in CKD; the potential submission of the sNDA with PK/PD Data for the Autoinjector; our ability to fund the Company through expected profitability; participation in upcoming events and presentations; and the timing of any of the foregoing. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include but are not limited to, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates; risks related to the receipt of regulatory approval for our product candidates; risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved; risks related to our history of operating losses, we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; we may never achieve or maintain profitability; we may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts; the terms of our credit facility place restrictions on our operating and financial flexibility, and we may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due; clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and any difficulties or delays in the commencement or completion, or the termination or the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; and the risk that global economic factors and uncertainties will impact the Company’s operations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. Katherine MirandascPharmaceuticals Inc., 781-301-6869kmiranda@scpharma.com Investors:Nick ColangeloGilmartin Group, 339-225-1047Nick@GilmartinIR.com scPharmaceuticals Inc. Unaudited Consolidated Statements of Operations (in thousands, except share and per share data) THREE MONTHS ENDED SEPTEMBER 30, NINE MONTHS ENDED SEPTEMBER 30, 2023 2024 2023 2024 Product revenues, net$3,796 $10,026 $7,497 $24,182 Operating expenses: Cost of product revenues$1,079 $3,311 $2,038 $7,396 Research and development 3,421 3,541 8,471 8,944 Selling, general and administrative 14,135 21,320 37,127 56,275 Total operating expenses 18,635 28,172 47,636 72,615 Loss from operations (14,839) (18,146) (40,139) (48,433)Loss on extinguishment of debt - (13,032) - (13,032)Change in fair value of term loan - (2,954) - (2,954)Change in fair value of revenue purchase and sale liability - (1,830) - (1,830)Other (expense) income (36) 1,804 1,193 3,587 Interest income 1,301 903 3,979 2,444 Interest expense (2,060) (1,850) (6,031) (6,085)Net loss$(15,634) $(35,105) $(40,998) $(66,303)Net loss per share, basic and diluted$(0.41) $(0.75) $(1.07) $(1.60)Weighted—average common shares outstanding, basic and diluted 38,760,895 46,558,484 38,421,676 41,516,917 scPharmaceuticals Inc. Unaudited Consolidated Balance Sheet Data (in thousands) DECEMBER 31, SEPTEMBER 30, 2023 2024 Cash, cash equivalents and investments $76,013 $91,484 Working capital 79,804 108,065 Total assets 94,479 125,069 Term loan 38,811 51,099 Revenue purchase and sale liability — 26,830 Accumulated deficit (281,346) (347,649)Total stockholders’ equity 37,218 30,709

First randomized placebo-controlled trial in NTM abscessusSymptom-based endpoints showed favorable improvement in frequency and severity of the most common symptomsMicrobiologic endpoints showed higher conversion to negative sputum culture, without emergence of resistance to omadacyclineIn this 12-week study, omadacycline appeared to be safe and well-tolerated with no new or unexpected safety signals BOSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for serious diseases, today announced top-line results from its Phase 2b study of oral omadacycline in adult patients with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc). “The results from this first-ever placebo-controlled trial in MABc patients are exciting and support the idea that omadacycline has clinical utility in this very challenging disease setting. Omadacycline treatment demonstrated positive results across multiple clinical and microbiological endpoints in the study,” said Kevin Winthrop, M.D., M.P.H., Center for Infectious Disease Studies, at Oregon Health and Science University and Principal Investigator in the study, “The results suggest its potential to become an important addition to the very limited treatment options currently available for patients with Mycobacterium abscessus, providing hope for improved patient outcomes. This is something that clinicians and patients in the NTM community should be very encouraged by.” The Phase 2b double-blind, placebo-controlled, randomized study evaluated the safety, efficacy, and tolerability of omadacycline in patients with Mycobacterium abscessus pulmonary disease. Sixty-six patients were randomized 1.5:1 to treatment with omadacycline (n= 41) or placebo (n=25) for 84 days, followed by a 30-day safety follow-up period. While the study was not designed to formally test for statistical differences between treatment arms, a trend favoring omadacycline was consistently observed across top line primary and secondary endpoints. The primary efficacy endpoint was the response on the NTM Symptom Assessment Scale at Day 84 and was evaluated 2 different ways. The first (Evaluation 1) defined a positive response as an improvement in at least 50% of the NTM symptoms present at baseline. The second (Evaluation 2) was a more stringent approach, requiring improvement in at least 50% of the NTM symptoms present at baseline AND no worsening of any baseline symptom. Omadacycline-treated subjects demonstrated a favorable trend towards higher response rates compared with placebo-treated subjects for both Evaluation 1 (34.1% vs 20%; p = 0.218) and Evaluation 2 (34.1% vs 12%; p = 0.046). The Quality of Life-Bronchiectasis (QOL-B), a patient-reported outcomes measure, favored omadacycline across all domains, particularly in vitality, physical functioning, social functioning, and respiratory symptoms. In addition, both patient and clinician assessments of clinical status improved over time in the omadacycline-treated group, while the placebo group showed worsening or no change. On microbiological endpoints, omadacycline-treated patients had a higher rate of negative sputum cultures for MABc (56.4% vs 29.2%, p=0.035) and a greater reduction in semi-quantitative sputum culture scores (76.5% vs 45.8%, p=0.017) at day 84 compared to placebo. Oral omadacycline administered for up to 12 weeks was generally safe and well-tolerated. The safety profile was consistent with the established profile for NUZYRA® (omadacycline), and no new safety signals were observed over this treatment period. The most common treatment-emergent adverse events were gastrointestinal symptoms. No deaths occurred in the study. Two subjects in the placebo-group experienced serious adverse events. Treatment discontinuation due to adverse events occurred in four (9.8%) omadacycline-treated patients. “These findings add to a growing dataset that supports the potential for symptomatic and microbiological improvement with omadacycline for those patients struggling with MABc pulmonary disease.” said Evan Loh, M.D., Chief Executive Officer of Paratek Pharmaceuticals. “This community needs better treatment options. I want to thank the patients, caregivers, and investigators who participated and made this encouraging outcome possible.” Analysis of all study data is ongoing and the complete data from this study will be presented in the future and published in a peer-reviewed journal. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative treatments for life-threatening diseases and other public health threats. Paratek’s lead product, NUZYRA® (omadacycline), is a novel antibiotic that addresses serious community-acquired infections. The company is dedicated to advancing solutions that address critical unmet medical needs, including those for rare and difficult-to-treat diseases such as NTM. For more information, visit www.paratekpharma.com or follow us on LinkedIn and Twitter. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and X.com. About NUZYRA® NUZYRA® (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. MEDIA CONTACT: Sarah Misheksmishek@scientpr.com