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Avenue Therapeutics Reaches Deal With FDA For Phase 3 Safety Study For IV Tramadol

RTTNews | 581 hari yang lalu

Avenue Therapeutics Reaches Deal With FDA For Phase 3 Safety Study For IV Tramadol

(RTTNews) - Specialty pharmaceutical company Avenue Therapeutics, Inc. (ATXI) announced Thursday that it has reached final agreement with the U.S. Food and Drug Administration on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous (IV) tramadol

Tramadol is in development for the treatment of acute post-operative pain in a medically supervised setting. The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. IV tramadol demonstrated safety and efficacy in this same surgical model in two Phase 3 efficacy trials.

The primary endpoint is a composite of elements indicative of respiratory depression. Avenue believes the study can be completed within 12 months and submitted to the FDA to address the CRL and potentially lead to approval of IV tramadol.

Teg: ATXI

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Japan June Current Account Surplus Y1.348 Trillion

Japan June Current Account Surplus Y1.348 Trillion

Japan posted a current account surplus of 1.348 trillion yen in June, the Ministry of Finance said on Friday - down 23.6 percent from a year earlier.

RTTNews | 9 minit yang lalu

Singapore Bourse Due For Profit Taking On Friday

Singapore Bourse Due For Profit Taking On Friday

The Singapore stock market has climbed higher in four straight sessions, gathering more than 100 points or 2.4 percent along the way. The Straits Times Index now sits just beneath the 4,260-point plateau although investors may lock in gains on Friday.

RTTNews | 19 minit yang lalu

Japan Household Spending Slumps 5.2% In June

Japan Household Spending Slumps 5.2% In June

The average of household spending in Japan was down a seasonally adjusted 5.2 percent on month in June, the Ministry of Internal Affairs and Communications aid on Friday - coming in at 316,085 yen.

RTTNews | 43 minit yang lalu

Malaysia Stock Market May Be Stuck In Neutral On Friday

Malaysia Stock Market May Be Stuck In Neutral On Friday

The Malaysia stock market has moved higher in three straight sessions, collecting more than 20 points or 1.5 percent along the way. The Kuala Lumpur Composite Index now sits just beneath the 1,550-point plateau although it's due for consolidation on Friday.

RTTNews | 49 minit yang lalu

Win Streak May End For Japan Stock Market

Win Streak May End For Japan Stock Market

The Japan stock market has moved higher in three consecutive sessions, advancing more than 760 points or 1.9 percent along the way. The Nikkei 225 now sits just shy of the 41,060-point plateau although it may spin its wheels on Friday.

RTTNews | 1j 4min yang lalu

South Korea Shares May Run Out Of Steam On Friday

South Korea Shares May Run Out Of Steam On Friday

The South Korea stock market has moved higher in four straight sessions, advancing almost 110 points or 3.6 percent along the way. The KOSPI now sits just above the 3,225-point plateau although the rally may stall on Friday.

RTTNews | 1j 19min yang lalu

Japan Data On Tap For Friday

Japan Data On Tap For Friday

Japan will release a batch of data on Friday, headlining a modest day for Asia-Pacific economic activity. On tap are June figures for household spending and current account and July numbers for bank lending and the eco watchers survey.

RTTNews | 2j 19min yang lalu

U.S. Dollar Rises As Waller Emerges As Potential Fed Chair Successor

U.S. Dollar Rises As Waller Emerges As Potential Fed Chair Successor

The U.S. dollar climbed against its most major counterparts in the New York session on Thursday, as Federal Reserve governor Christopher Waller emerged as a top candidate to replace Chair Jerome Powell.

RTTNews | 3j 6min yang lalu

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