Nektar's NDA submission is supported by an extensive clinical and nonclinical data package. The clinical data submitted in the NDA comprised 15 studies in 2,234 subjects and includes a 600-patient efficacy study in patients with chronic low back pain who are new to opioid therapy; a 630-patient long-term 52-week safety study in patients with noncancer pain, who are new to opioid therapy, as well as those who are experienced with opioid therapy; pharmacokinetic/ pharmacodynamic studies in over 450 subjects; and two human abuse potential studies evaluating both therapeutic and supratherapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users.
NKTR-181 is an investigational medicine and has not been approved by the
About Chronic Low Back Pain
Low back pain is the second most common cause of disability for adults in the U.S.1 Approximately 149 million work days are lost every year because of low back pain, with total costs estimated to be
NKTR-181 is the first long-acting, selective full mu-opioid receptor agonist designed to provide potent pain relief, without the inherent high levels of euphoria, which contribute to abuse and addiction with opioids. The novel molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier in order to slow its rate of entry into the brain and attenuate the dopamine release that underlies euphoria. In addition, NKTR-181 has a 14-hour elimination half-life to enable twice-daily dosing for pain control.
Current and past strategies of abuse deterrence to address the abuse potential properties of standard opioids rely on formulations alone. However, all abuse-deterrent formulations are pre-cursors to highly euphorigenic rapid-acting opioids, which can be liberated through tampering.
NKTR-181 is not a prodrug, a reformulation, or a drug product formulated for sustained release of an existing opioid. Nonclinical and clinical data show that the inherent properties of NKTR-181 reduce its rate of entry into the brain compared to standard mu opioids, regardless of route of administration.3
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "design," "leads to," "address," "can," "will," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential therapeutic benefit of NKTR-181 for treating patients with low back pain, the potential importance of NKTR-181 in addressing opioid abuse, the risks of opioid abuse resulting from use of NKTR-181, and certain other statements regarding the prospects and potential of NKTR-181. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) challenges and uncertainties inherent in the regulatory review of new drugs, where the risk of failure remains high due to negative determinations by the
1. Arch Intern Med 2009