We apply our drug delivery technologies to products we market through Ther-Rx Corporation.
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Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena® and Compounded 17P Formulations
St. Louis, MO – November 8, 2011 – Recent testing conducted by independent laboratories, commissioned by Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company (the “Company”) (NYSE: KV.A/KV.B), shows that multiple samples of both compounded 17P drug formulations and active pharmaceutical ingredient (API) that may be used in compounded 17P failed to meet certain established standards for potency and purity. These findings, which have been submitted to the U.S. Food and Drug Administration (FDA), demonstrate important quality differences in these compounded 17P formulations when compared to FDA-approved Makena® (hydroxyprogesterone caproate injection).
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What concerns did healthcare providers have about unapproved progesterone formulations before Makena (hydroxyprogesterone caproate injection) became available?
Prior to approval of Makena by the U.S. Food and Drug Administration (FDA), women who could benefit from therapy faced potential barriers to access due to the absence of a commercially-available, FDA-approved product. A survey of obstetricians/gynecologists published in the American Journal of Perinatology in March 2009 highlights concerns about availability in the absence of an FDA-approved product. More than one in three ob/gyns were “very concerned” about unapproved progesterone formulations not being easily available.1
What is the company doing to ensure women have access to Makena now that it is available?
We believe ensuring access to an FDA-approved sterile, injectable medication, manufactured under mandatory strict quality controls, is in the best interests of clinically eligible patients. As part of its ongoing efforts, Ther-Rx Corporation enacted important initiatives to reduce the cost of Makena to insurance companies and work with stakeholders to help provide access to this important FDA-approved medication including:
- Providing supplemental rebates to commercial insurers.
- Offering supplemental rebates to Medicaid plans in addition to the standard Medicaid rebate of at least 23.1 percent, resulting in a substantially reduced cost per injection for state Medicaid agencies compared to list price.
- Expanding the patient assistance program for patients who are prescribed Makena by removing upper-level income caps to qualify for financial assistance.
Who is eligible for the Makena Patient Financial Assistance Program?
With our Patient Assistance Programs, clinically eligible patients can have affordable access to therapy.* Financial assistance is available for clinically eligible insured and uninsured patients upon request.
The Makena Co-pay Assistance Program will reduce co-pay costs for insured patients whose health plan covers Makena™. Patients with a household income of up to $120,000† will pay between $0 and $20 per injection for Makena. Since there are no income caps, patients with a household income greater than $120,000 are also eligible for co-pay assistance.
The Makena Patient Assistance Program supports uninsured patients by offering the drug at no cost or reduced cost. Patients who are uninsured and have an annual household income less than $60,000 will receive Makena at no out-of-pocket cost.
What is the Makena Care ConnectionTM?
The Makena Care Connection is a program for patients and healthcare providers that offers administrative, financial and treatment support for Makena. Because specialty injectable products like Makena are not typically carried by retail pharmacies, the process for facilitating prescriptions for Makena is managed by this dedicated customer support center.
Ther-Rx established the Makena Care Connection to help facilitate the process of prescribing and obtaining Makena for healthcare providers and patients. The Makena Care Connection is actively processing prescriptions for Makena, and is facilitating access to the patient financial assistance program for patients who need financial support.
The FDA based its approval of Makena in part on a study conducted by the National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units Network. Did the NICHD study use compounded 17P?
No. The NICHD study did not use 17P from compounding pharmacies using the compounding process.
As part of the FDA’s Investigational New Drug (IND) guidelines, the drug supplies used in the NICHD study were manufactured under FDA’s Good Manufacturing Practices (GMPs) conditions – the same conditions under which FDA-approved Makena is manufactured.2 These conditions provide control and monitoring of the manufacturing process and facilities by ensuring the identity, strength, quality, and purity of the medication.3 Drugs not approved by the FDA, such as compounded 17P, are not subject to the same requirements.10
Because the NICHD study served as the basis for FDA approval of Makena, Makena is required by FDA to be manufactured under the same conditions as in the NICHD study. FDA-approved Makena—a sterile injectable—is manufactured in a facility compliant with current Good Manufacturing Practices (cGMPs). These FDA-enforced regulations help ensure the identity, strength, quality, and purity of the medication by requiring control and monitoring of the manufacturing process and facilities. This also helps ensure consistency from dose to dose and accurate potency according to the amount declared on the label.3 Adherence to these quality-management systems means your patients will receive the FDA-approved formulation for this indication.4
On October 13, 2011, ACOG and SMFM issued an information update on hydroxyprogesterone caproate.
Is KV investing in any other clinical studies to learn more about Makena?
Yes. Requirements for FDA approval of Makena include major, multi-year follow-on clinical studies of Makena involving more than 1,700 mothers and more than 500 infants. These studies, required by the FDA as a condition for Makena’s approval, began enrolling patients in 2009 (prior to FDA approval) and are being funded by KV Pharmaceutical Co.5 These studies are approximately four times larger and approximately 12 times more expensive than the initial NICHD trial submitted for FDA approval. These studies will help provide enhanced medical knowledge to patients, families, and society as a whole.
What is the difference between FDA-approved medications and compounded drugs?
Prescription drugs, including generic drugs, are regulated by the Food and Drug Administration (FDA). Drug companies seeking approval to sell a drug in the United States must test it to determine how the drug works, if it's safe, and if it provides a real health benefit. The company then sends the data from these tests to FDA to prove the drug is safe and effective for its intended use. A team of FDA physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.6
Compounded drugs are not regulated by the FDA. Pharmacy compounding is provided by a pharmacist when a commercially manufactured drug is unavailable or not suitable for a specific patient.7 Pharmacists compound specialized medications in response to prescriptions written by doctors for people with unique medical needs.8 Some compounded drugs may present risks to patients because these drugs have not been evaluated for safety and effectiveness by FDA, or if they have been improperly compounded.7
What is the difference between compounded medications and generic medications?
Prescription drugs, including generic drugs, are regulated by the FDA.6 Generic drugs are chemical equivalents of approved brand name drugs that have themselves been reviewed and approved by FDA.9
Compounded drugs are not regulated by the FDA and are not classified as generic drugs. Pharmacy compounding is provided by a pharmacist when a commercially manufactured drug is unavailable or not suitable for a specific patient.7
What is the difference between FDA-approved Makena and compounded
17P?
Compounded 17P is an unapproved drug that is not regulated by the FDA. Pharmacy compounding is provided by a pharmacist when a commercially manufactured drug is unavailable or not suitable for a specific patient.7
FDA-approved Makena—a sterile injectable—is manufactured in a facility compliant with current Good Manufacturing Practices (cGMPs). These FDA-enforced regulations help ensure the identity, strength, quality, and purity of the medication by requiring control and monitoring of the manufacturing process and facilities. This also helps ensure consistency from dose to dose and accurate potency according to the amount declared on the label.3 Adherence to these quality-management systems means patients will receive the FDA-approved formulation for this indication.4 Makena is the only product for this indication that has been studied in clinical trials conducted by the NICHD and subsequently reviewed and approved by the FDA.
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Makena is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions:
- Current or history of thrombosis or thromboembolic disorders
- Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors, benign or malignant, or active liver disease
- Uncontrolled hypertension
Makena should be discontinued if thrombosis or thromboembolism occurs.
Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil.
Women receiving Makena should be monitored if they:
- Are prediabetic or diabetic
- Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
- Have a history of clinical depression; Makena should be discontinued if depression recurs
- Develop jaundice; consider whether benefit of use warrants continuation
- Develop hypertension
Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%).
The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%).
Please click here for Makena™ Prescribing Information.
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Visit
www.makena.com for additional information regarding
Makena.
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