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SteadyMed Announces Positive Clinical Study Results in Support of SMT-201 for the Treatment of Post Surgical Pain in the Home Setting

SAN RAMON, Calif., Oct. 28, 2015 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced positive results from the completion of a Phase 1 pharmacokinetic (PK), tolerability and safety, proof of concept clinical study with ketorolac, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term treatment of moderately severe acute pain post-surgery. The results from this study were favorable and support further development of the Company's SMT-201 At Home Patient Analgesia (AHPA) program. SMT-201 is a combination of SteadyMed's PatchPump® technology and ketorolac, that is intended to provide patients with up to five days of post-surgical pain relief at the opioid level in the home setting from a non-opioid therapy.

The current standard of care for ketorolac therapy must be initiated in the hospital or surgical center with either intravenous (IV) infusion or multiple intra-muscular (IM) injections. The study data demonstrated that a continuous subcutaneous infusion of ketorolac over 24 hours resulted in equivalent bioavailability compared to IM injections administered at six-hour intervals over 24 hours. In addition, this continuous 24-hour subcutaneous infusion avoided the peaks and troughs in plasma concentration that were associated with the ketorolac IM injections.

Jonathan Rigby, President and CEO of SteadyMed, commented, "Over 70 million surgeries are performed annually in the United States. The inability to effectively manage post-surgical pain can delay recovery from surgery and may result in an increased length of hospital stay, increased hospital readmission rates and higher healthcare costs. Despite the introduction of new pain management modalities, both patients and their health care providers continue to face issues with treating post-surgical pain in the home setting."

Mr. Rigby continued, "Ketorolac provides pain relief at the opioid level but currently has limited utility because of the need for therapy initiation by IV infusion or IM injection in the hospital over a 24-hour period. SteadyMed's goal is to change this and bring effective post-surgical pain management into the home setting. We believe that these positive Phase 1 results support this goal and, by advancing the clinical development of SMT-201, may ultimately allow patients to return home sooner after minor surgery while continuing to receive effective, non-opioid pain relief."

SteadyMed's Phase 1 PK proof of concept clinical study enrolled 12 healthy subjects who received 120 mg of ketorolac over 24 hours as either a continuous subcutaneous infusion (5 mg/hr) or 4 IM injections of 30 mg each every 6 hours over 24 hours in a randomized, crossover study design. The bioavailability of both treatments demonstrated similar area under the curve (AUC) results. The continuous infusion demonstrated zero order kinetics consistent with ketorolac concentration levels needed for a therapeutic effect without the peaks and troughs in plasma concentration seen in the IM arm of the study. Both routes of administration were generally safe and well tolerated. Ketorolac is a potent NSAID that provides analgesia comparable to some opioids but without the side effects associated with a narcotic agent.

SteadyMed expects to further advance its clinical development program in 2016 with the full integration of ketorolac with its PatchPump technology, a pre-filled, disposable, drug administration platform that is pre-programmed to deliver a liquid drug at the correct infusion rate, potentially improving patients' quality of life.

About SteadyMed

SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. The company's lead drug product candidate is Trevyent®, a development stage drug product that combines SteadyMed's PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension. PatchPump is a proprietary, disposable, parenteral drug administration platform that is prefilled and preprogrammed at the site of manufacture. SteadyMed intends to commercialize Trevyent in the U.S. and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements concerning the company's ability to advance its development-stage product candidates, including Trevyent and SMT-201. Forward-looking statements reflect the company's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our most recent Quarterly Report on Form 10-Q filed on August 13, 2015. The company does not undertake to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date hereof except as may be required by law.

CONTACT: Marylyn Rigby Director, Investor Relations and Marketing 925-272-4999 mrigby@steadymed.com Robert H. Uhl Managing Director Westwicke Partners 858-356-5932 robert.uhl@westwicke.com

Source: SteadyMed Therapeutics