Malvern-based Endo Health Solutions will be a stock to watch Monday when the stock market opens because of Friday evening's news that the FDA had rejected the company's request to stop generic competitors to Endo's Opana ER opioid painkiller.
The FDA announcement came after the trading closed Friday. But word of the pending announcement leaked out enough that trading was halted Friday before the market closed.
The company said - after the FDA decision and after the market closed - that the agency ruling might cost Endo $120 million in revenue for the rest of 2013.
Endo (ENDP) trades on the NASDAQ. The stock was at $34, down about 3 percent, around 10 a.m.
Endo had pulled Opana ER and marketed what it said was a more tamper-resistant pill. Opioid drug abusers crush, snort, liquefy and inject such painkillers - and there are others - which has translated into more deaths from overdose than those caused by cocaine and heroin.
Endo submitted a citizen's petition, seeking to have the withdrawal officially determined to be for safety reasons - which would then mean generic competitors without tamper-resistant formulations should also be withdrawn or not approved.
The FDA decided Endo was acting more out of commercial concerns than safety concerns. Indeed, the FDA statement said that in some ways, the news version might be more easily abused.
The full FDA statement and then the full company statement from Friday are below:
FDA Statement: Original Opana ER Relisting Determination
The U.S. Food and Drug Administration (FDA) today responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.
The petition was submitted by Endo Pharmaceuticals Inc., the sponsor of original Opana ER and a reformulated version, also called Opana ER, which was designed with the goal of being more difficult to abuse and misuse. After an extensive, science-based review, FDA concluded based on the available data and information that the original formulation of Opana ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, FDA has denied the manufacturer’s petition.
FDA conclusions include:
- While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing.
- Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.
- The postmarketing investigations are inconclusive, and even if one were to treat available data as a reliable indicator of abuse rates, one of these investigations also suggests the troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.
FDA continues to encourage the development of abuse-deterrent formulations of opioids to help reduce prescription drug abuse and to positively affect public health. FDA reviews every application on its own merits, based on applicable scientific and legal standards. The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. Abuse-deterrent properties must be supported by sound science taking into consideration the totality of the data for the particular drug at issue.
Abuse deterrent formulations are an important tool to help address misuse of medication. In addition, both prescriber and patient education is vital to safe and effective opioid use. FDA encourages all opioid prescribers to take advantage of valuable training, available as of March 1, 2013, to help ensure they have adequate and up-to-date training in opioid therapy. FDA urges all prescribers to ensure patients using opioids are appropriately informed of the risks and benefits of these drugs and fully understand directions for their use. The opioid drug labeling also provides prescriber information related to patient education.
Endo Health Solutions
Endo Health Solutions Responds to FDA’s Denial of OPANA(R) ER Citizen Petition and the Potential Approval of Additional Non-Abuse Deterrent Formulations of Generic Oxymorphone
MALVERN, Pa., May 10, 2013 /PRNewswire/ — Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals Inc. Endo presented FDA data collected from an ongoing epidemiology study that indicate that per 100,000 prescriptions dispensed, the past 30-day abuse rate of crush-resistant OPANA ER was 79 percent lower than the abuse rate of generic versions of extended-release oxymorphone that were on the market in 2012.
Endo, through its Citizen Petition, requested that FDA: — Determine that the original, non-abuse deterrent formulation of OPANA ER was withdrawn from sale for reasons of safety, as is supported, in part, by the ongoing epidemiology studies — Refuse to approve any abbreviated new drug applications that referenced the non-abuse deterrent version of OPANA ER — Suspend the approvals of generic formulations of OPANA ER currently on the market.
The FDA decided that the original formulation of OPANA ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed. Additionally, FDA issued a complete response to Endo’s supplemental new drug application requesting the addition of labeling language describing the abuse-deterrent properties of OPANA ER.
"We are extremely disappointed and disagree with today’s decision, and believe that the approval of non-abuse deterrent formulations of long acting opioids will contribute to a significant increase in prescription drug abuse," said Rajiv De Silva, president and chief executive officer of Endo Health Solutions. "With the approval and expected launch of additional non-abuse deterrent generic versions of OPANA ER, we will carefully assess Endo’s position in the competitive landscape and explore all options, including those intended to mitigate the effect of this decision. Endo remains committed to patient safety, including appropriate use of our products, as a top priority."
Endo’s financial guidance for 2013 included an assumption that FDA would remove generic versions of OPANA ER from the market by mid-year. In isolation, Endo estimates that the denial of the Citizen’s Petition and the potential launch of multiple generic formulations of non-abuse deterrent oxymorphone could reduce 2013 total net sales of OPANA ER by up to $120 million and reduce adjusted diluted EPS by up to approximately $0.55 in 2013. However, the company is actively pursuing cost-reduction actions that will reduce the earnings effect of FDA’s decision. Endo will provide an update to its 2013 guidance on or before the second quarter financial results conference call in August.
About OPANA ER OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
WARNING: ABUSE POTENTIAL, LIFE THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
Abuse Potential OPANA ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OPANA ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA ER for signs of misuse, abuse, and addiction during treatment.
Life-threatening Respiratory Depression Respiratory depression, including fatal cases, may occur with use of OPANA ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and OPANA ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole. Crushing, dissolving, or chewing OPANA ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.
Accidental Exposure Accidental ingestion of OPANA ER, especially in children, can result in a fatal overdose of oxymorphone. Interaction with Alcohol The co ingestion of alcohol with OPANA ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on OPANA ER.
Endo Health Solutions Inc. (Endo) is a U.S.-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates value for patients, providers and payers alike. Learn more at www.endo.com.